The Position Arcus Biosciences is seeking a Principal Statistical Scientist with broad responsibility for providing high-quality statistical expertise to assigned clinical studies and exploratory work at Arcus. He or she will look beyond the purely statistical aspects, collaborating to promote rigor in the planning, conduct, and analysis of experiments, as well as to guide the interpretation and reporting of results. The position will work directly with senior biostatisticians and will interact with a diverse group of internal and external stakeholders. The Principal Statistical Scientist initially will have statistical oversight responsibilities for clinical studies in our lung cancer and early oncology development spaces. This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of (immuno-)oncology therapeutics. The ideal candidate will be motivated to integrate into clinical study teams, establish cross-functional partnerships, and have an interest in conducting exploratory data analyses involving new and diverse data types including, for example, exploratory or translational biomarker analyses in support of our clinical development plans. Job Duties and Responsibilities Serves as a biostatistician on clinical development teams and partners with other functions in the planning, design, analysis, and reporting and communication of results (internally and externally) In partnership with senior statisticians, develops fit-for-purpose clinical trial designs, with decision-making operating characteristics, power, sample size and timeline considerations, as well as other development needs addressed via their statistical toolset Ensures data and analysis quality - including working with external statistical vendors, contractors or consultants - when generating formal or informal tables, listings and figures Demonstrates a learning mindset by developing or adopting innovative, fit-for-purpose statistical methods, or tools to address scientific questions, engage in exploratory work, or support internal decision-making Builds solid collaborations with cross-functional clinical team members as well as internal and external data-facing stakeholders Keeps abreast of new developments in statistics, drug development and regulatory guidance and requirements through literature review and professional activities Qualifications Education/Experience PhD in biostatistics, statistics, mathematics or a related field. MS considered with appropriate additional experience 3+ years of biotechnology or pharmaceutical industry experience; clinical oncology experience is a strong plus Sound understanding of theoretical and applied statistics Fluency with standard statistical software (SAS or R). R programming skills a must. Strong analytical skills and demonstrated experience in gathering, analyzing, interpreting, reporting and presenting data Knowledge of industry standards for clinical data collection and data base structure, e.g., CDISC guidelines for SDTM and ADaM data sets for both CRF and non-CRF data Professional/Personal Requirements Ability to work independently on multiple projects, anticipate challenges and defend positions based on science and sound data analysis Ability to effectively communicate statistical concepts to non-statisticians Prior experience with biomarker data (especially routine companion diagnostic and/or next-gen sequencing data) and a firm understanding of biological assays is a strong plus Subject matter knowledge in the areas oncology or immunology will be a strong plus as will any specialty expertise related to one or more partner functions, e.g., clinical pharmacology, preclinical or translational research and development, bioinformatics, CMC/manufacturing, etc.
03/04/2021
Full time
The Position Arcus Biosciences is seeking a Principal Statistical Scientist with broad responsibility for providing high-quality statistical expertise to assigned clinical studies and exploratory work at Arcus. He or she will look beyond the purely statistical aspects, collaborating to promote rigor in the planning, conduct, and analysis of experiments, as well as to guide the interpretation and reporting of results. The position will work directly with senior biostatisticians and will interact with a diverse group of internal and external stakeholders. The Principal Statistical Scientist initially will have statistical oversight responsibilities for clinical studies in our lung cancer and early oncology development spaces. This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of (immuno-)oncology therapeutics. The ideal candidate will be motivated to integrate into clinical study teams, establish cross-functional partnerships, and have an interest in conducting exploratory data analyses involving new and diverse data types including, for example, exploratory or translational biomarker analyses in support of our clinical development plans. Job Duties and Responsibilities Serves as a biostatistician on clinical development teams and partners with other functions in the planning, design, analysis, and reporting and communication of results (internally and externally) In partnership with senior statisticians, develops fit-for-purpose clinical trial designs, with decision-making operating characteristics, power, sample size and timeline considerations, as well as other development needs addressed via their statistical toolset Ensures data and analysis quality - including working with external statistical vendors, contractors or consultants - when generating formal or informal tables, listings and figures Demonstrates a learning mindset by developing or adopting innovative, fit-for-purpose statistical methods, or tools to address scientific questions, engage in exploratory work, or support internal decision-making Builds solid collaborations with cross-functional clinical team members as well as internal and external data-facing stakeholders Keeps abreast of new developments in statistics, drug development and regulatory guidance and requirements through literature review and professional activities Qualifications Education/Experience PhD in biostatistics, statistics, mathematics or a related field. MS considered with appropriate additional experience 3+ years of biotechnology or pharmaceutical industry experience; clinical oncology experience is a strong plus Sound understanding of theoretical and applied statistics Fluency with standard statistical software (SAS or R). R programming skills a must. Strong analytical skills and demonstrated experience in gathering, analyzing, interpreting, reporting and presenting data Knowledge of industry standards for clinical data collection and data base structure, e.g., CDISC guidelines for SDTM and ADaM data sets for both CRF and non-CRF data Professional/Personal Requirements Ability to work independently on multiple projects, anticipate challenges and defend positions based on science and sound data analysis Ability to effectively communicate statistical concepts to non-statisticians Prior experience with biomarker data (especially routine companion diagnostic and/or next-gen sequencing data) and a firm understanding of biological assays is a strong plus Subject matter knowledge in the areas oncology or immunology will be a strong plus as will any specialty expertise related to one or more partner functions, e.g., clinical pharmacology, preclinical or translational research and development, bioinformatics, CMC/manufacturing, etc.
Regeneron Pharmaceuticals, Inc.
Basking Ridge, New Jersey
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.
01/15/2021
Full time
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.
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York
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.
01/15/2021
Full time
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.
Description: Our client is looking for a Senior Biostatistician for their NNJ offices. The right candidate will: Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed. May work on submission teams as a statistician and/or a programmer. Generate and QC outputs for publications; review publication (abstract/man====ripts) to ensure accuracy, quality and soundness of statistical methodologies Will serve as Lead Statistician on complex trials and across multiple studies. Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes. Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed. QUALIFICATIONS: Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry. Strong SAS programming skills. Oncology experience is required. Ability to effectively work on multiple projects Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. Applies good judgment and leads problem solving within the team Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus. Thanks and Regards, Ali Sarwar ARAXIS SYSTEMS INC. Email ID: - provided by Dice
10/02/2020
Full time
Description: Our client is looking for a Senior Biostatistician for their NNJ offices. The right candidate will: Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed. May work on submission teams as a statistician and/or a programmer. Generate and QC outputs for publications; review publication (abstract/man====ripts) to ensure accuracy, quality and soundness of statistical methodologies Will serve as Lead Statistician on complex trials and across multiple studies. Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes. Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed. QUALIFICATIONS: Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry. Strong SAS programming skills. Oncology experience is required. Ability to effectively work on multiple projects Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. Applies good judgment and leads problem solving within the team Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus. Thanks and Regards, Ali Sarwar ARAXIS SYSTEMS INC. Email ID: - provided by Dice
Hi, We have an exciting opportunity for the role of "Senior Biostatistician" with our client. Please check the job description as below and let me know your interest. In case you are not looking for any change, I'd appreciate if you could refer any friends/ colleagues who might be interested in it. Title: Senior Biostatistician Duration: 12+ Months Location: Jersey city, NJ Description: Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed. May work on submission teams as a statistician and/or a programmer. Generate and QC outputs for publications; review publication (abstract/man====ripts) to ensure accuracy, quality and soundness of statistical methodologies Will serve as lead Statistician on complex trials and across multiple studies. Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes. Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed. QUALIFICATIONS: Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry. Strong SAS programming skills. Oncology experience is required. Ability to effectively work on multiple projects Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. Applies good judgment and leads problem solving within the team Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus. - provided by Dice
10/02/2020
Full time
Hi, We have an exciting opportunity for the role of "Senior Biostatistician" with our client. Please check the job description as below and let me know your interest. In case you are not looking for any change, I'd appreciate if you could refer any friends/ colleagues who might be interested in it. Title: Senior Biostatistician Duration: 12+ Months Location: Jersey city, NJ Description: Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed. May work on submission teams as a statistician and/or a programmer. Generate and QC outputs for publications; review publication (abstract/man====ripts) to ensure accuracy, quality and soundness of statistical methodologies Will serve as lead Statistician on complex trials and across multiple studies. Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes. Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed. QUALIFICATIONS: Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry. Strong SAS programming skills. Oncology experience is required. Ability to effectively work on multiple projects Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. Applies good judgment and leads problem solving within the team Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus. - provided by Dice
Contract job working for my company. The job will be on site when the site opens back up. Must be able to work for my company directly. EZ3385 Senior Biostatistician duration 1 year rate $80 - $90 hr. W2. Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed. May work on submission teams as a statistician and/or a programmer. Generate and QC outputs for publications; review publication (abstract/man====ripts) to ensure accuracy, quality and soundness of statistical methodologies Will serve as lead Statistician on complex trials and across multiple studies. Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes. Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed. QUALIFICATIONS: Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry. Strong SAS programming skills. Oncology experience is required. Ability to effectively work on multiple projects Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. Applies good judgment and leads problem solving within the team Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus. - provided by Dice
10/01/2020
Full time
Contract job working for my company. The job will be on site when the site opens back up. Must be able to work for my company directly. EZ3385 Senior Biostatistician duration 1 year rate $80 - $90 hr. W2. Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed. May work on submission teams as a statistician and/or a programmer. Generate and QC outputs for publications; review publication (abstract/man====ripts) to ensure accuracy, quality and soundness of statistical methodologies Will serve as lead Statistician on complex trials and across multiple studies. Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes. Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed. QUALIFICATIONS: Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry. Strong SAS programming skills. Oncology experience is required. Ability to effectively work on multiple projects Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. Applies good judgment and leads problem solving within the team Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus. - provided by Dice
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York
Regeneron's motto is Science to Medicine. Within Medical Analytics, our motto is Data Science to Medicine. We are looking for an innovative, collaborative and creative Biostatistician to join our growing Medical Analytics group who will apply state-of-the-art analytical methods to the service of patients. Bring your ideas, sharpen your analytical tools, and dive head first into data exploration. Our more recent work includes: Application of machine learning methods to identify patients who will best benefit from our treatments Data visualization methods to effectively communicate complex results in simple yet informative (and beautiful) ways Contribute ideas to publication plans, innovative study designs, propose new endpoint definitions and, of course, innovative statistical analysis methods In this role, a typical day might include the following: Partner with Medical Affairs and HEOR colleagues to: Further analyze clinical data: With a solid understanding of clinical studies and databases as the foundation, go beyond traditional trial reporting to explore and discovery new insights to fully unlock and leverage the rich clinical database. HEOR and market access support: With a growing emphasis in the payer and reimbursement areas, perform analyses to support HEOR including patient reported outcomes as well as analyses for health technology assessments (HTA). Design new medical and RWE studies: Understand the needs to different stakeholders (beyond regulatory agencies) and design studies appropriately. Develop the Medical Analytics organization and also yourself in the process: Strategy: Help shape strategy as well as develop processes within Medical Analytics. Define statistical standards: Define statistical standards and work together with Medical Analytics statistical programming to build our internal SAS macro library. Explore innovative statistical methods: Delve deeper into various research questions and consider alternative statistical methods. This job might be for you if: You have strong learning agility: Understand the therapeutic area from a scientific perspective and be able to translate the new discovery of information into scientific publications and/or study design ideas. You have strong communication and collaboration skills: Be able to fluently interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical colleagues. In cross-functional and cross-company alliance settings or with senior leadership and external scientific experts, be able to drive and lead discussions and present results. You have the ability to roll up your sleeves and get the work done: Be able to simultaneously work on current problems while thinking of future solutions. To be considered for the Biostatistician role, you must have a PhD in statistics or biostatistics with 0 - 3 years of pharmaceutical industry or relevant experience. Demonstrated experience in statistical methods to support Medical Affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials). Experience in statistical methods to support Health Economics and Outcomes Research including meta-analysis, patient reported outcomes (including development/validation), HTA/reimbursement/value dossiers, and real-world studies. Experience in statistical methods to support new studies including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, and pragmatic clinical trials. At least 5 years using SAS to solve statistical problems as well as experience with sample size calculation software. 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. #LI-EH1
09/28/2020
Full time
Regeneron's motto is Science to Medicine. Within Medical Analytics, our motto is Data Science to Medicine. We are looking for an innovative, collaborative and creative Biostatistician to join our growing Medical Analytics group who will apply state-of-the-art analytical methods to the service of patients. Bring your ideas, sharpen your analytical tools, and dive head first into data exploration. Our more recent work includes: Application of machine learning methods to identify patients who will best benefit from our treatments Data visualization methods to effectively communicate complex results in simple yet informative (and beautiful) ways Contribute ideas to publication plans, innovative study designs, propose new endpoint definitions and, of course, innovative statistical analysis methods In this role, a typical day might include the following: Partner with Medical Affairs and HEOR colleagues to: Further analyze clinical data: With a solid understanding of clinical studies and databases as the foundation, go beyond traditional trial reporting to explore and discovery new insights to fully unlock and leverage the rich clinical database. HEOR and market access support: With a growing emphasis in the payer and reimbursement areas, perform analyses to support HEOR including patient reported outcomes as well as analyses for health technology assessments (HTA). Design new medical and RWE studies: Understand the needs to different stakeholders (beyond regulatory agencies) and design studies appropriately. Develop the Medical Analytics organization and also yourself in the process: Strategy: Help shape strategy as well as develop processes within Medical Analytics. Define statistical standards: Define statistical standards and work together with Medical Analytics statistical programming to build our internal SAS macro library. Explore innovative statistical methods: Delve deeper into various research questions and consider alternative statistical methods. This job might be for you if: You have strong learning agility: Understand the therapeutic area from a scientific perspective and be able to translate the new discovery of information into scientific publications and/or study design ideas. You have strong communication and collaboration skills: Be able to fluently interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical colleagues. In cross-functional and cross-company alliance settings or with senior leadership and external scientific experts, be able to drive and lead discussions and present results. You have the ability to roll up your sleeves and get the work done: Be able to simultaneously work on current problems while thinking of future solutions. To be considered for the Biostatistician role, you must have a PhD in statistics or biostatistics with 0 - 3 years of pharmaceutical industry or relevant experience. Demonstrated experience in statistical methods to support Medical Affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials). Experience in statistical methods to support Health Economics and Outcomes Research including meta-analysis, patient reported outcomes (including development/validation), HTA/reimbursement/value dossiers, and real-world studies. Experience in statistical methods to support new studies including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, and pragmatic clinical trials. At least 5 years using SAS to solve statistical problems as well as experience with sample size calculation software. 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. #LI-EH1