Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Position leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical analysis plan and helps in interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also works on statistical methodology and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal programmers in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Responsibilities: Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer. Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines. Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities. Global strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: PhD in statistics or biostatistics or Master's in Statistics/Biostatistics. Ph.D. strongly preferred. Minimum 3 years relevant experience in the pharmaceutical industry with Ph.D. or 5 years with Masters. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, Job Title Manager, Biostatistics City Basking Ridge Functional Area Biostatistics & Data Management State New Jersey
01/19/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Position leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical analysis plan and helps in interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also works on statistical methodology and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal programmers in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Responsibilities: Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer. Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines. Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities. Global strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: PhD in statistics or biostatistics or Master's in Statistics/Biostatistics. Ph.D. strongly preferred. Minimum 3 years relevant experience in the pharmaceutical industry with Ph.D. or 5 years with Masters. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, Job Title Manager, Biostatistics City Basking Ridge Functional Area Biostatistics & Data Management State New Jersey
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