36 jobs found

Description SHIFT: Day Job SCHEDULE: Full-time Your Talent. Our Vision. At HealthCore, Inc. , an independently-operating subsidiary of Anthem, Inc. and a health services research firm, it's a powerful combination. It's the foundation upon which we're creating greater access to care for our members, greater value for our customers and greater health for our communities. Join us and together we will drive the future of health care. Preferred Location: Wilmington, DE or Watertown, MA Primary responsibilities may include, but are not limited to: Analyzes healthcare claims and clinical data using accepted statistical and biostatistical techniques. Contributes to the design of research studies and statistical analytic plans. Oversees analysis and execution of statistical analysis plans, performs quality control, and interprets the results for research projects. Prepares detailed specifications for study databases and analysis files, consistency checks, tables, and figures; communicates requirements to the programming group. Manipulates and creates complex analysis datasets. Investigates, analyzes, and evaluates complex statistical/programming issues, develop/implement data quality assurance plans; collaborates and/or communicates with internal teams, data management and clients regarding these issues. Summarizes results of requested analysis in table and graphic format. Plans statistical programming activities and schedules to provide project team with guidance on data management and analysis timelines for projects. Responds to and manages ad hoc client requests to ensure accurate, in-depth results/data are delivered in a timely manner. Prepares research results and written summaries to internal teams or clients, and for journal publications; Participates in the writing of manripts, especially Statistical Method and Result sections. Reviews and recommends revisions to presentations that contain his/her work. Supports initiatives to improve efficiency and standardization in research analytics. Responds to ad hoc client requests to ensure accurate, in-depth results/data are delivered in a timely manner. Provides technical/analytical advice to staff. Qualifications Requires a Masters degree in Biostatistics, Statistics or related field; 3 years healthcare and/or consumer data analysis experience; 2+ years experience in the development of predictive models; 3 years coding experience with SAS; 3 years experience manipulating and processing large multi-source datasets with SAS and SQL programming tools; or any combination of education and experience, which would provide an equivalent background. Experience with industry standard clinical code sets preferred. Anthem, Inc. is ranked as one of America's Most Admired Companies among health insurers by Fortune magazine and has been named a 2019 Best Employers for Diversity by Forbes. To learn more about our company and apply, please visit us at careers.antheminc.com. An Equal Opportunity Employer/Disability/Veteran. Anthem promotes the delivery of services in a culturally competent manner and considers cultural competency when evaluating applicants for all Anthem positions. - provided by Dice

Description SHIFT: Day Job SCHEDULE: Full-time Your Talent. Our Vision. At HealthCore, Inc. , an independently-operating subsidiary of Anthem, Inc. and a health services research firm, it's a powerful combination. It's the foundation upon which we're creating greater access to care for our members, greater value for our customers and greater health for our communities. Join us and together we will drive the future of health care. Preferred Location: Wilmington, DE or Watertown, MA Primary responsibilities may include, but are not limited to: Analyzes healthcare claims and clinical data using accepted statistical and biostatistical techniques. Contributes to the design of research studies and statistical analytic plans. Oversees analysis and execution of statistical analysis plans, performs quality control, and interprets the results for research projects. Prepares detailed specifications for study databases and analysis files, consistency checks, tables, and figures; communicates requirements to the programming group. Manipulates and creates complex analysis datasets. Investigates, analyzes, and evaluates complex statistical/programming issues, develop/implement data quality assurance plans; collaborates and/or communicates with internal teams, data management and clients regarding these issues. Summarizes results of requested analysis in table and graphic format. Plans statistical programming activities and schedules to provide project team with guidance on data management and analysis timelines for projects. Responds to and manages ad hoc client requests to ensure accurate, in-depth results/data are delivered in a timely manner. Prepares research results and written summaries to internal teams or clients, and for journal publications; Participates in the writing of manripts, especially Statistical Method and Result sections. Reviews and recommends revisions to presentations that contain his/her work. Supports initiatives to improve efficiency and standardization in research analytics. Responds to ad hoc client requests to ensure accurate, in-depth results/data are delivered in a timely manner. Provides technical/analytical advice to staff. Qualifications Requires a Masters degree in Biostatistics, Statistics or related field; 3 years healthcare and/or consumer data analysis experience; 2+ years experience in the development of predictive models; 3 years coding experience with SAS; 3 years experience manipulating and processing large multi-source datasets with SAS and SQL programming tools; or any combination of education and experience, which would provide an equivalent background. Experience with industry standard clinical code sets preferred. Anthem, Inc. is ranked as one of America's Most Admired Companies among health insurers by Fortune magazine and has been named a 2019 Best Employers for Diversity by Forbes. To learn more about our company and apply, please visit us at careers.antheminc.com. An Equal Opportunity Employer/Disability/Veteran. Anthem promotes the delivery of services in a culturally competent manner and considers cultural competency when evaluating applicants for all Anthem positions. - provided by Dice

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. In this role a typical day may include the following: With supervision and mentorship from senior departmental staff, provide support to a clinical study team and strategic project team on all relevant statistical matters. Working directly with the medical directors and study personnel, act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis. Defend design at management forums (DPR and PRC). With supervision and mentorship from senior departmental staff, contribute to design of a clinical study and help draft protocols or amendments. Perform sample size calculations. Develop statistical analysis plan (SAP). Perform analyses and author statistical methods and results sections of the clinical study report (CSR). Provide statistical insight into interpretation and discussion of study results. Contributes tables and figures for management presentations. Under limited supervision and mentorship of experienced statisticians, contributes to clinical trial teams. Attends GCST and SPT on programs to represent department. Independently prepares TFLs to support CSRs, DSURs, IB and documents. Collaborates with Medical Writing and Clinical to ensure tables are complete. Supports TFL production for ISE/ISS for submissions. Contributes to regulatory submissions. Under mentorship of senior staff, supports preparation of material to be used in regulatory interactions, including drafting analysis plan under supervision/mentorship and production of TFLs to be used in regulatory meetings, slides for ACMs, etc. Supplies to authoring of regulatory background packages, including those for pre-IND, EOP2, and pre-BLA meetings. Will give background material for ACMs and perform additional analyses as required for labeling negotiations. Attends pre-IND, EOP2, and pre-BLA meetings with experienced statistician. Supplies to working groups by developing new methodology and conducting simulation studies under the supervision of senior departmental staff. Supplies to revising SOPs. This role may be for you if: You have a PhD or equivalent degree in statistics/biostatistics or related subject areas with >2 years work experience, OR MS with >3 years work experience at Sr Biostatistician level. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Description SHIFT: Day Job SCHEDULE: Full-time Your Talent. Our Vision. At HealthCore, Inc. , an independently-operating subsidiary of Anthem, Inc. and a health services research firm, it's a powerful combination. It's the foundation upon which we're creating greater access to care for our members, greater value for our customers and greater health for our communities. Join us and together we will drive the future of health care. Preferred Location: Wilmington, DE or Watertown, MA Primary responsibilities may include, but are not limited to: Analyzes healthcare claims and clinical data using accepted statistical and biostatistical techniques. Contributes to the design of research studies and statistical analytic plans. Oversees analysis and execution of statistical analysis plans, performs quality control, and interprets the results for research projects. Prepares detailed specifications for study databases and analysis files, consistency checks, tables, and figures; communicates requirements to the programming group. Manipulates and creates complex analysis datasets. Investigates, analyzes, and evaluates complex statistical/programming issues, develop/implement data quality assurance plans; collaborates and/or communicates with internal teams, data management and clients regarding these issues. Summarizes results of requested analysis in table and graphic format. Plans statistical programming activities and schedules to provide project team with guidance on data management and analysis timelines for projects. Responds to and manages ad hoc client requests to ensure accurate, in-depth results/data are delivered in a timely manner. Prepares research results and written summaries to internal teams or clients, and for journal publications; Participates in the writing of manripts, especially Statistical Method and Result sections. Reviews and recommends revisions to presentations that contain his/her work. Supports initiatives to improve efficiency and standardization in research analytics. Responds to ad hoc client requests to ensure accurate, in-depth results/data are delivered in a timely manner. Provides technical/analytical advice to staff. Qualifications Requires a Masters degree in Biostatistics, Statistics or related field; 3 years healthcare and/or consumer data analysis experience; 2+ years experience in the development of predictive models; 3 years coding experience with SAS; 3 years experience manipulating and processing large multi-source datasets with SAS and SQL programming tools; or any combination of education and experience, which would provide an equivalent background. Experience with industry standard clinical code sets preferred. Anthem, Inc. is ranked as one of America's Most Admired Companies among health insurers by Fortune magazine and has been named a 2019 Best Employers for Diversity by Forbes. To learn more about our company and apply, please visit us at careers.antheminc.com. An Equal Opportunity Employer/Disability/Veteran. Anthem promotes the delivery of services in a culturally competent manner and considers cultural competency when evaluating applicants for all Anthem positions. - provided by Dice

The Principal Biostatistician assumes responsibility for methodological and statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area lead biostatistician. Provide leadership and mentorship on statistical matters to interdepartmental clinical / regulatory teams. In some cases incumbent could serve as specialist in a particular statistical area or application. In this role a typical day may include the following: Work with the clinical and regulatory functions to define study endpoints and perform relevant sample size calculations. Develop statistical analysis plan (SAP) With mentorship from senior departmental staff, assume leadership role for providing statistical support to one or more study teams on all statistical matters. Act as direct liaison to the study team. Own the definition and documentation of derived variables needed to produce planned TFL. Assume responsibility for accuracy of derived variables. Expertise and some practical experience in use of advanced statistical methodologies, especially with application to clinical trial design and analysis Lead all aspects of execution of the statistical analysis according to the SAP and preparation of the statistical methods and results sections for the clinical study report (CSR). Provide support for the study team to move CSR through the review and approval process. Provide statistical insight into interpretation and discussion of study results Produce / coordinate production of statistical summaries, analyses, reports, and materials for submission to regulatory authorities or to independent monitoring committees. Review submission documents, such as IND, BLA, or CTD to insure statistical validity and accuracy response to Health Authorities from countries Collaborate with project team on the production of the clinical development plan (CDP). Work with senior departmental staff to develop statistical position on studies or project issues acting as a representative to extended project team. Provide input to Therapeutic Area lead biostatistician on project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers. This role might be for you if: PhD + 0 year experience or MS + 6 yrs biotech / pharma experience in statistics or area with 6 to 8+ years of experience in different phases of a trial Knowledge of pharmaceutical / biotech clinical development with the ability to use statistical methods to assess/improve efficiency and effectiveness in drug development Expertise with experience in using advanced statistical methodologies, applicable to clinical trial design and analysis Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices, e.g., CTD guidance, ICH guidelines Support NDA/sDNA submission and respond to FDA queries. EMA type II submission experience and in respond to Health Authorities from other countries Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in multiple therapeutic areas / indications Familiarity and practical experience in design, production, and use of submission-quality electronic datasets. Ability to define and meet study / project timelines for deliverables such as protocol, clinical study summaries, and key analyses Strong interpersonal skills, experience leading internal teams, extensive leadership skills and extensive outsourcing project managing experience with CROs. Ability to coordinate, lead, and empower teams. Proficiency with SAS, S-Plus/R, Sample size calculation software (e.g., EAST and Nquery) Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

ul,p {width:100%;} The Emmes Company, LLC is searching for a Senior Biostatistician located in our Burnaby, Canada office. Emmes provides flexibility for office location preference or work remote preference dependent upon position. The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Primary Purpose Leads collaborations with clinical investigators to determine study design, contributes to protocol development, authors statistical analysis plans, performs statistical analysis, makes statistical inference and writes and presents reports summarizing findings including publications in peer-reviewed journals. Manages statistical activities for a clinical study or platform of clinical studies. Responsibilities Provides sound strategic, scientific and statistical input to support client's research projects. Serves as the lead Biostatistician on one or more study projects. May supervise Biostatisticians, Associate Biostatisticians and SAS programmers (all levels) and direct their work on clinical research studies. Leads the project team's development of study analysis plans and statistical programs to perform analyses and display study data. Keeps abreast with current statistical and medical literature to ensure that sound methodologies are adopted. Fosters innovation in Biostatistics that will continuously enhance current statistical knowledge and practices. Ensures the scientific integrity of the research project and the accuracy of the reported results. Performs sample size calculation and provides leadership in the statistical design of research projects. Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained. Develops study assignment allocation schemas along with appropriate documentation. Leads the development of the methods and results sections of clinical study reports and scientific publications. Represents EMMES on behalf of clients at regulatory meetings. Participate in the development and updating of Standard Operating Procedures. Other duties as assigned Experience MS in biostatistics, statistics, or related field. At least 4 years of related experience is expected but not required for the position. Demonstrated proficiency with statistical methods and applications in clinical research. Strong programming skills in SAS and/or R. Excellent communication, interpersonal and organization skills. Ability to manage multiple tasks. Ability to work independently, as well as in a team environment. Ability to effectively communicate technical concepts, both written and oral. CONNECT WITH US!! Follow us on Twitter Find us on LinkedIn - The Emmes Company, LLC The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

ul,p {width:100%;} The Emmes Company, LLC is searching for a Biostatistician - Project Leader located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia Office. Emmes provides flexibility for office location or work remote preference dependent upon position. The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Primary Purpose The Project Leader-Biostatistician is accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business. Provides statistical guidance and direction to project. Responsibilities Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance Identifies statistical issues, proposes solutions and consults with other statisticians throughout the company on project-related statistical issues Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies Reviews, provides input on, and approves project and study documents and processes, as needed Represents the project or company at client meetings and scientific conferences Utilizes broad understanding of therapeutic, clinical trial design, statistical and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable. Uses established key performance metrics to assure successful delivery of the project that meet client requirements Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate Contributes to the development of operational strategy, budget, and proposal content for new business opportunities Experience PhD in Biostatistics, Statistics, Epidemiology with at least 3 years of relevant work experience to include management experience Demonstrated working knowledge of the principles of clinical research management Demonstrated experience in applying statistical expertise to the design and analysis of clinical research studies Experience in protocol development, statistical analysis, and manuscript writing Demonstrated leadership and project management experience Strong programming abilities in SAS and/or R Excellent verbal and written communication skills Excellent problem solving and collaboration skills Subject matter expertise in respective area of specialization Demonstrated excelling project leader skills CONNECT WITH US!! Follow us on Twitter Find us on LinkedIn - The Emmes Company, LLC The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected

ul,p {width:100%;} The Emmes Company, LLC is searching for a Biostatistician based out of our Rockville, Maryland or Frederick, Maryland office. Emmes provides flexibility for the office location or work remote preference dependent upon position . The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We provide statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Primary Purpose The Biostatistician collaborates with clinical investigators to determine study design, contributes to protocol development, writes statistical analysis plans, performs statistical analysis and inference and writes and presents reports summarizing findings including publications in peer-reviewed journals. The Biostatistician develops systems for monitoring the quality of clinical data. The Biostatistician ensures high-quality statistical support is provided for clinical trials, registries and basic research using advanced statistical skills and knowledge of clinical research. The Biostatistician maintains expertise in state-of-the-art data manipulation and statistical methodology. Responsibilities Collaborates with clinical investigators to determine study design Writes sections of protocols that require statistical input Reviews protocols and case report forms to ensure that protocol objectives are met and standards are maintained Generates treatment allocations in randomized clinical research studies and ensures proper implementation Leads the project team's development of statistical analysis plans and programs to perform analyses and display study data Performs statistical analyses, writes and validates application programs Implements data and safety monitoring reports to ensure participants safety Develops metrics and generates quality control reports to optimize the performance of clinical sites and the coordinating center Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies Authors or contributes to manuscripts and/or scientific presentations Participates in professional development activities both within and outside the company Experience PhD in Biostatistics, Statistics, or Epidemiology Demonstrated proficiency with statistical methods and applications in clinical research Competent in SAS programming language and/or R Expertise in state-of-the-art data manipulation and statistical methodology Ability to manage multiple tasks Ability to work independently, as well as in a team environment Ability to effectively communicate technical concepts, both written and oral CONNECT WITH US!! Follow us on Twitter Find us on LinkedIn - The Emmes Company, LLC The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

ul,p {width:100%;} The Emmes Company, LLC is searching for a Senior Biostatistician Manager located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for office location or work remote preference, dependent upon position. The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Primary Purpose The Senior Biostatistician Manager oversees statistical activities and deliverables across a broad research area, Provides guidance and oversight to other senior statistical staff and ensures timely and high-quality completion of statistical activities. Responsibilities Manages a team of Biostatistician Managers and is responsible for statistical deliverables across a broad research area Serves as a client point of contact for statistical deliverables on large projects, fostering a collaborative relationship with contract sponsors and Emmes project team members Manages statistical resources (i.e. budget and personnel) across a broad research area to ensure statistical tasks are completed on schedule and that each project has adequate staffing levels Develops strategic vision for the department in collaboration with the Director of Biostatistics Across a broad research area at Emmes, serves as the identified internal point of contact for other corporate and senior project staff for management of budgeting, staffing, and statistical activities Participates in recruiting activities for new statistical staff members and makes hiring decisions Serves as a statistical expert and provides consultation to projects across the company Supervises and mentors senior statistical staff, promotes career development and growth for senior staff Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings) Establishes budgets for statistical activities on new project work Identifies statistical and operational issues and proposes solutions Prepares, reviews and/or approves clinical project material that requires statistical input to ensure that the documents are scientifically valid and feasible Reviews work processes, schedules and checklists to ensure that all routine activities, as documented in corporate and project-specific Standard Operating Procedures (SOPs), are efficiently performed Participates in project and corporate quality assurance activities, particularly those of a statistical nature Ensures that project staff is trained and mentored, supervises project staff and performs personnel reviews Provides project updates to Director of Biostatistics Other duties as assigned Experience MS or PhD in statistics, biostatistics, epidemiology or related field required At least 7 (with PhD) or 10 (with MS) years of related experience required; including leading a clinical research team and supervising senior level statistical staff Expertise in state-of-the-art data manipulation and statistical analyses Proven effective leadership of a clinical research team Strong skills in prioritization, problem-solving, organization, decision-making, time management, negotiation, mentoring and planning Self-motivated, proactive and detail-oriented Demonstrated ability to manage multiple tasks, while working independently Ability to effectively communicate technical concepts, both written and oral CONNECT WITH US!! Follow us on Twitter Find us on LinkedIn - The Emmes Company, LLC The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

ul,p {width:100%;} The Emmes Company, LLC is searching for a PhD Biostatistician based out of our Burnaby, Canada office. Emmes provides flexibility for the office location or work remote preference dependent upon position . The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We provide statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Primary Purpose The Biostatistician collaborates with clinical investigators to determine study design, contributes to protocol development, writes statistical analysis plans, performs statistical analysis and inference and writes and presents reports summarizing findings including publications in peer-reviewed journals. The Biostatistician develops systems for monitoring the quality of clinical data. The Biostatistician ensures high-quality statistical support is provided for clinical trials, registries and basic research using advanced statistical skills and knowledge of clinical research. The Biostatistician maintains expertise in state-of-the-art data manipulation and statistical methodology. Responsibilities Collaborates with clinical investigators to determine study design Writes sections of protocols that require statistical input Reviews protocols and case report forms to ensure that protocol objectives are met and standards are maintained Generates treatment allocations in randomized clinical research studies and ensures proper implementation Leads the project team's development of statistical analysis plans and programs to perform analyses and display study data Performs statistical analyses, writes and validates application programs Implements data and safety monitoring reports to ensure participants safety Develops metrics and generates quality control reports to optimize the performance of clinical sites and the coordinating center Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies Authors or contributes to manuscripts and/or scientific presentations Participates in professional development activities both within and outside the company Experience PhD in Biostatistics, Statistics, or Epidemiology Demonstrated proficiency with statistical methods and applications in clinical research Competent in SAS programming language and/or R Expertise in state-of-the-art data manipulation and statistical methodology Ability to manage multiple tasks Ability to work independently, as well as in a team environment Ability to effectively communicate technical concepts, both written and oral CONNECT WITH US!! Follow us on Twitter Find us on LinkedIn - The Emmes Company, LLC The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

ul,p {width:100%;} Emmes Services Pvt. Ltd , ("Emmes") is searching for Senior Biostatistician in Clinical Research located in our Bangalore, India office. Emmes provides flexibility for office location preference, dependent upon position. EMMES Services Pvt. Ltd, Bangalore, a fully owned subsidiary of The Emmes Company, LLC. Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Primary Purpose The Biostatistician collaborates with clinical investigators to determine study design, contributes to protocol development, writes statistical analysis plans, performs statistical analysis and inference and writes and presents reports summarizing findings including publications in peer-reviewed journals. The Biostatistician develops systems for monitoring the quality of clinical data. The Biostatistician ensures high-quality statistical support is provided for clinical trials, registries and basic research using advanced statistical skills and knowledge of clinical research. The Biostatistician maintains expertise in state-of-the-art data manipulation and statistical methodology. Primary Purpose The Biostatistician collaborates with clinical investigators to determine study design, contributes to protocol development, writes statistical analysis plans, performs statistical analysis and inference and writes and presents reports summarizing findings including publications in peer-reviewed journals. The Biostatistician develops systems for monitoring the quality of clinical data. The Biostatistician ensures high-quality statistical support is provided for clinical trials, registries and basic research using advanced statistical skills and knowledge of clinical research. The Biostatistician maintains expertise in state-of-the-art data manipulation and statistical methodology. Responsibilities Collaborates with clinical investigators to determine study design. Writes sections of protocols that require statistical input. Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained. Generates treatment allocations in randomized clinical research studies and ensures proper implementation. Leads the project team's development of statistical analysis plans and programs to perform analyses and display study data. Performs statistical analyses, writes and validates application programs. Implements data and safety monitoring reports to ensure participants safety. Develops metrics and generates quality control reports to optimize the performance of clinical sites and the coordinating center. Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies. Applies, guides and ensures others on team are implementing QC processes, ensuring deliverables are accurate, are of high quality and delivered on agreed timelines. Authors or contributes to manuscripts and/or scientific presentations. Participates in professional development activities both within and outside the company. Ensure timely and effective communication of project milestones and status to internal stakeholders. Assists the cross functional communication for smooth deliverables of study related documents. Works with multi-disciplinary teams Experience Requires a master's or PhD degree in Statistics with minimum of 4-7 years of clinical research experience. Solid understanding of design of experiments; Demonstrated proficiency with statistical methods and applications in clinical research. Competent in SAS programming language and/or R. Expertise in state-of-the-art data manipulation and statistical methodology. Ability to manage multiple tasks. Ability to work independently, as well as in a team environment. Ability to effectively communicate technical concepts, both written and oral. Ability to lead / drive departmental initiatives (with Supervision). CONNECT WITH US!! Follow us on Twitter Find us on LinkedIn - The Emmes Company, LLC The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Principal Biostatistician This position can be filled at any location - Wilmington, DE, Watertown, MA, Andover, MA or Alexandria, VA. Clients health services research firm, is seeking a Principal Biostatistician with experience in the healthcare consulting or biopharmaceutical industry to join our dynamic company. Founded in 1996, and now an independently-operating subsidiary provides the health care system, biopharmaceutical industry, academia, and the Federal Government with "real-world " data to improve the quality, safety, and affordability of healthcare. projects range from retrospective to large-scale, prospective studies in the areas of drug, vaccine, and medical device safety surveillance, risk management, pharmacoepidemiology , health outcomes, pharmacoeconomics , and comparative effectiveness research. The Principal Biostatistician is responsible for leading and oversight of expert clinical research analysis for the Biostatistical reporting team. Primary duties may include, but are not limited to: Lead statistical activities on complex and/or multiple clinical research projects; Meet with statistical team to review and prioritize tasks, provide advice and guidance, and review work Collaborate with investigators and sponsors on protocol development; Oversee quality control with project statisticians executing analyses Resolve statistical issues brought for escalation Oversee and execute on the development of project reports, such as reports for DSMB , FDA or clinical study reports for sponsor; Collaborate with investigators and co-authors on the writing of study manripts, generate concepts or provide feedback on concepts, develop and execute analysis plan Qualifications Requires a PhD and 7+ years of postdoctoral research experience with increasing responsibility; or Master's degree and 11+ years of experience; or any combination of education and experience, which would provide an equivalent background. Exhibited publications record and established areas of research. Statistical applications must include high level of proficiency with SAS, and other appropriate analysis software packages as R and PASS. In addition to a dynamic work environment, client offers a competitive salary and an outstanding benefits program including a 401(k) plan; health, dental, and vision insurance; discounted fitness club membership; life, AD&D, short and long-term disability insurance coverage; tuition assistance, and an employee stock purchase plan and free parking. Security Clearance Required: No Visa Candidate Considered: No. Client is unable to sponsor visa. CANDIDATE DETAILS: 7+ to 10 years experience Seniority Level -Mid-Senior Management Experience Required -No Minimum Education -Doctorate Degree Willingness to Travel -Occasionally IDEAL CANDIDATE Experience in clinical research; clinical trial development (drugs, treatment, devices etc.) Experience conducting analysis (applied) on projects. Experience in research, but also to lead the statistical/project team to Client out the plan/strategy of the project, and getting involved in review and ensuring the quality of the work. Ability to lead for statistical aspects and be able to provide consultations and make decisions to move the projects forward. PhD candidate with a minimum of 8 years after the PhD OR Master's degree and 11+ years of experience Additionally, the PHD is very specific and requires experience with Clinical Trials. - provided by Dice

Biostatistician II Large, growing Medical Device Company in Tucson needs a bright, SAS savvy Biostatistician to help out with their team. Working from home is allowed during COVID and beyond as long as you are open to working AZ business hours. Provides statistical support to development and clinical research projects; interacts with research personnel to ascertain needs and develops appropriate design and statistical solutions. Writes statistical analysis plans (SAPs) and statistical reports for use by internal and external customers. Responsibilities • Interacts with development and clinical investigators to designs clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims. • Writes data analysis plans as needed to capture design elements and statistical methodology. • Performs data analysis and prepares statistical reports of results. • Performs Quality Control (QC) for statistical analyses by other biostatisticians to ensure analysis quality. • Conducts randomization and blinding of samples. • Develops data entry spreadsheets as needed. • Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility. • Maintains expertise in state-of-the-art data manipulation and statistical analyses. • Manages technical aspects of project(s), as assigned. • Monitors work to ensure quality, and continuously promotes Quality First Time. Skills and Experience Masters plus 3 years' statistical analysis in a healthcare environment or PhD plus significant experience in analysis and reporting using statistical software -Experience with SAS -Design of Experiments (DOE) experience -Experience in FDA submissions and in vitro diagnostic tests Knowledge, Skill or Ability • Knowledge of FDA guidelines for in vitro diagnostic devices and the required statistical basis for sensitivity, specificity, agreement rates, and reproducibility testing required for validation and FDA clearance and approval. • Strong ability to collaborate across departments and interact with various levels in the organization. • High attention to detail with skill in producing organized reports. • Ability to write statistical code and documentation. • Ability to work in a team-focused environment. Apply today for immediate consideration to EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice

Albireo Pharma Overview: Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver or gastrointestinal diseases and disorders. Albireo has deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. The company's first commercial launch will be Odevixibat, which is a potent and selective inhibitor of the ileal bile acid transporter (IBAT), sometimes referred to as the apical sodium dependent bile acid transporter (ASBT), that has minimal systemic exposure at therapeutic doses and acts locally in the gut. Albireo is developing Odevixibat initially to treat patients with PFIC, a rare genetic liver disease, and plans to consider additional development in other pediatric cholestatic liver diseases and disorders in the future. Our Phase 3 program in PFIC includes a single randomized, double-blind, placebo controlled, multicenter clinical trial and an open-label long-term extension study. The double-blind trial, called PEDFIC1, is underway with data read out anticipated in mid- 2020. The U.S. Food and Drug Administration (FDA) has granted to the Odevixibat PFIC program or elements of its fast track, rare pediatric disease and orphan drug designations. The European Medicines Agency (EMA) has granted Odevixibat orphan designation, as well as access to the Priority Medicine's (PRIME) scheme for the treatment of PFIC. Its Pediatric Committee has agreed to Albireo's Odevixibat Pediatric Investigation Plan for PFIC. Both FDA and EMA also have granted orphan drug designation to Odevixibat for the treatment of Alagille syndrome and primary biliary cholangitis. Albireo will commercialize Odevixibat in the US, Europe & Canada and is pursuing potential partners in remaining regions. Position Summary: Reporting to VP of Biometrics , the Director of biostatistics within the Biometrics Department is expected to act independently as the statistics subject matter expert for all clinical development programs and studies, including oversight of data management and statistical programming activities, while ensuring adherence to all regulatory requirements. H/she is responsible for providing broad statistical support and contributing strategically to project decisions, with a focus on clinical planning, study design, protocol development, sample size / power calculations and simulations, statistical analysis methodology, statistical analysis plan preparation, blinded in-trial data quality review, pre-database lock data quality control, supporting development of table / listing / figure templates, programming and production, oversight of contract or CRO resources, as well as preparation, integration and documentation of clinical regulatory submission package, in accordance with CDISC standards. The Lead Biostatistician is expected to have an in-depth understanding of advanced statistical methods, including innovative trial designs and endpoints, missing data and multiplicity handling. She/he will have a thorough understanding and capability to implement state-of-the-art innovative statistical methodology for the design, execution and evaluation of clinical trials. In addition, she/he will have the capacity to understand the relevant multi-disciplinary knowledge and interact effectively within the biometrics deparment and also with clinicians, clinical operations, medical writing, regulatory affairs, information technology and other colleagues, service/technology providers, as well as external drug development agencies or organizations. She/he will have a good understanding and the capacity to sustain the dialog in consultations or advisory board meetings with biostatistical, clinical and regulatory key opinion leaders about clinical study design, execution and evaluation from the statistical perspective. Key Duties and Responsibilities: Extensive collaboration with integrated clinical teams to design studies, develop statistical analysis plans, and draft statistical reports / manuscripts for clinical studies in all phases for FDA/MAA, as well as for other global regulatory authorities Provide strategic and statistical input to Albireo clinical programs and clinical study teams, as well as advisory board or expert meetings Actively contribute to what and how data are collected, be familiar with CDISC data structure, formatting and documentation standards for clinical studies, as well as integrated safety and efficacy datasets Review documents related to clinical data management, including (e)CRFs, EDC, eSource/eCOA/ePRO and data management validation plans and their deployment Prepare randomization specifications and generate or oversee the setup of randomization processes and systems, including enrichment trial designs Plan, program and execute sample size and assumptions calculations and simulations for conventional, adaptive and enrichment trial designs, reflecting the actual methodology planned for the study evaluation, including statistical model, missing data and multiplicity handling, as well as sensitivity analyses Design, develop, modify, document and evaluate the technical data processes, systems and infrastructure to expedite and evaluate analysis and reporting of clinical studies Ensure accuracy, precision, efficiency, robustness in statistical planning, study design, statistical analysis, interpretation, reporting, and presentation of clinical study results Evaluate and interpret clinical trial data, write up reports, prepare slides and present results to internal and external stakeholders including regulatory agencies Assist in drafting and review of clinical study reports and statistical methodology and results sections of documents prepared for scientific communication (i.e., reports, manuscripts, posters, abstracts), including posting of results in public study registries Contribute to the selection, information, oversight and evaluation of expert consultants, contractors, CROs and other partners providing statistical services Participate in multi-disciplinary meetings and teleconferences and provide consulting, interpretive, and analytical support Identify and plan statistical tasks, timelines, resources and account for critical dependencies and resources in order to estimate, agree and ensure that statistical work meets deadline commitments and quality standards in a timely manner Lead projects by managing statistical tasks, resources, timelines and budgets as well as act as point of contact for internal and external teams including consultants, contractors, CROs and other vendors Contribute to the definition and oversight of the setup, methodology, tools decision rules, support and implementation of DMCs and ability to direct, mentor junior statisticians, data managers, and programmers Take an active role in task forces or process-improvement groups and assist in providing guidance related to biostatistics, programming, and data management Maintain exhaustive program and clinical trial documentation, including design, execution, evaluation, review, QC, tracking information, as well as internal and external communications Perform peer review of other statisticians' work; Perform QC of analysis datasets, data displays for efficacy and safety variables Qualifications: A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 10 years of relevant clinical biostatistics experience in pharma, biotech or medical device industry -OR- a Master's degree and a minimum of 12 years of relevant industry experience is required Experience of rare disease clinical development and NDA is highly preferred; Comprehensive knowledge of statistical theory and methods Demonstrated ability to apply statistical, programming, and data management knowledge to clinical studies and other supportive tasks Expertise in SAS and R programming for data management, conversion, review and visualization, statistical analysis, tabulation, listing and graphs of clinical trial data Excellent verbal and written communication skills; Leadership and team-ability with effective intercultural competences, diplomacy, negotiation and communication Self-management skills with the ability to take initiatives, develop and evaluate alternative scenarios and options, and present them effectively to the colleagues and leadership of the company Proficiency in MS Word, Excel, and PowerPoint software programs Excellent problem-solving and strategic-thinking skills Sound knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, etc.) Excellent written and oral communication and presentation skills Ability to identify and address issues proactively in a timely manner Ability to make appropriate, rational and well-justified decisions in ambiguous situations with incomplete or uncertain information; Ability to prioritize tasks and direct team accordingly

The Biostatistician II provides academic leadership, making important intellectual contributions especially related to statistics. Collaborates with clinical and non-clinical researchers and operational colleagues as part of an interdisciplinary team to design and conduct analytic studies; as well as interpret and report results. Provides statistically sound experimental and quasi-experimental designs and data analysis to meet project objectives in a responsive manner. Maintains current knowledge of new developments in statistics. Educates Baylor Scott & White on proper use and interpretation of statistics by developing and implementing statistical curriculum. Location/Facility Baylor Scott & White Research Institute For more information on the facility, please click our Locations link. Specialty/Department/Practice Clinical Research Shift/Schedule Day Shift Benefits Our competitive benefits package includes*: Immediate eligibility for health and welfare benefits 401(k) savings plan with dollar-for-dollar match up to 5% Tuition Reimbursement PTO accrual beginning Day 1 *Note: Benefits may vary based upon position type and/or level. QUALIFICATIONS EDUCATION Master's Degree EXPERIENCE A minimum of 2 years experience required

Job Description: Position: Biostatistics/SAS -Open Position-CA Type: contract Duration: 12 months Location: Pasadena, CA Education/License/Certification: Bachelor's degree in Computer Science, Biostatistics, Statistics, Mathematics, Information Systems, or related field of study. Essential Responsibilities: Perform analytical programming, data management, quality control and reporting for research projects including clinical trials. Extract, manipulate and merge large databases to create analytical datasets. Assist in defining analytical variables and help consulting with project staff on project needs. Maintain a professional relationship with project personnel. Perform simple analytical tasks using SAS or other analytical tools. Implement comprehensive quality checking and validation process. Maintain and troubleshoot software and programs. Design and generate tracking and data entry tools as needed. Implement automated reporting and data loading schemes. Convert and merge data from a wide variety of sources across platforms. Create and maintain documentation to document process and data quality issues. Perform other related duties incidental to work described herein. Additional Requirements: Ability to organize and manipulate large datasets. Ability to express complex technical information to researchers or to audiences with clinical training. Strong analytic and critical thinking skills, writing skills, communication skills and consulting skills. Must be an independent self-starter, but also able to work within a team. Both efficient and detail-oriented. Preferred Qualifications: Experience with medical or health research. Master of Public Health in Epidemiology or Biostatistics or Master of Science in Biostatistics Please do reply to me with your updated resume with the hourly rates ASAP Regards Sikandar - provided by Dice

AL Solutions have recently formed a new partnership with a small, exciting start-up biotechnology organisation that are a subsidiary of a larger collective group of research organisations based in North Carolina. This is a very exciting time to join my client as they are at the beginning of their journey and have very aggressive growth plans over the next 12-18 months. Due to this, my client can offer excellent career progression opportunities as they grow in the coming years. This position is ideal for someone who has recently graduated or someone looking for an organisation they can grow with. This position can be worked 100% from home in North Carolina and offer flexible start dates. *Responsibilities:* * Investigate and compare available algorithms, methods and data sources. * Contribute to the understanding and application of results by customers * Validate and deploy/update selected data sources. * Develop appropriate procedures for testing and validation of new or updated pipelines or pipeline components. * Write validation reports detailing validation methodology and results. * Write SOPs for new or updated pipeline components, or new pipelines. * Refine methodologies for data analysis, processing, visualization and storage *Requirements:* * Degree in a scientific related discipline * Previous background in bioinformatics, biostatistics or data science * Good working proficiency with Python/R programming * Strong hands-on skills in bioinformatics databases, bioinformatics tools and relevant programming languages. *Apply* AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you're interested, please apply below. If this position doesn't interest you, please visit our website for a list of more vacancies. *Jack Kavanagh* *AL Solutions*

Senior Biostatistician Remote Responsibilities Lead research design and analytical strategies, provide input into protocols, develop and review statistical analysis plans and author/co-author reports, abstracts and manripts Use your expertise to advise, provide guidance and to oversee the quality control of statistical deliverables. Lead the Biostatistical activities on a study and be accountable for the deliverables. Requirements PhD degree in biostatistics, mathematics, statistics, public health or related discipline with experience in statistical analysis of clinical trials data or MS degree in biostatistics, mathematics, statistics, public health or related discipline with years of experience in statistical analysis of clinical trials data. Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods. Proficiency in SAS statistical programming. Knowledge of other statistical and data management software packages is a plus. Strong written and oral communication skills. Knowledge and experience with CDISC data standards and models. Strong project management and mentoring/leadership skills. In-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (Google Cloud Platform) and International Conference on Harmonization (ICH) guidelines. Ability to effectively manage multiple tasks and projects. Ability to clearly describe statistical techniques and interpret results. THIRD PARTY AGENCIES, SUBCONTRACTORS, AND RECRUITERS NEED NOT APPLY. Applicants received from firms will not be considered. Subcontracting is not available for this position. - provided by Dice

*Senior Statistician - Salary up to $135,000 - Flexibility to work from the office in NC or home (USA)* This is a fantastic opportunity to join dynamic CRO who take pioneering, creative approaches, and implement them with quality and excellence. They are experts, bright thinkers, dreamers and doers and, together, they are changing the way the world experiences CROs, in the best possible way. They have got big plans to grow next year by close to a 1,000 hires. Building a corporate culture focused on embracing teamwork, being tenacious, taking ownership, acting with integrity and delivering with excellence. Get in touch to find out more about what makes them the change for the common CRO and how their award-winning, global team is improving lives around the world every day. This opportunity offers a competitive compensation package, a dynamic, friendly and supportive team, mentorship and training to further develop your skills and flexibility to work from the office or home as an option - how does that sound? *Senior Statistician role will involve:* The Senior Biostatistician independently manages statistical project support and provides expert statistical consultancy across the stats function. * Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met by expert and timely statistical consultancy and support. * Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing statistical analysis plans. * Provide project support to the statistics reporting process through the specification/review of tables, figures and listings shells, writing/review of derived dataset specifications and the formatting of report documents and tabulations. * Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings, and their validation. * Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation. * Provide support for the bidding process, including contribution to budget review, proposals, and bid defence meetings. * Maintain knowledge in design consultancy and analysis methodology, statistical software packages (e.g. SAS and nQuery) and regulatory guidance documents e.g. ICH, FDA, and CPMP points to consider. *Senior Statistician will have:* * Educated to degree level in mathematics, statistics or another subject with a strong statistical component. * Hands-on expert level project statistician experienced in providing statistical leadership to projects. * Design and analysis consultancy skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Erick Semerene on (0) and send your CV through to or use the apply button on this page.