Lead Biostatistician at SimulStat Incorporated

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Website SimulStat Incorporated

Lead Biostatistician

Contract
Remote
12 month renewable remote contract

The Study Lead Statistician (SLS) for product facing work is responsible for leading statistical activities of clinical studies. The SLS works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with Regulatory requirements and standards, and maintain statistical, as well as operational, integrity throughout the life of the study. The SLS works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. The SLS also works closely with the Study Statistician, who performs all the operational activities related to the statistics-related deliverables. The SLS is responsible for the integrity and quality of their study. The SLS also supports product level activities that could include Regulatory activities as well as publication work.
Responsibilities:

Support the General Medicine Group as a Lead Study Statistician for dozens of products currently in phase III, IIIb and IV
Provide statistical guidance, review, and contribution to protocols, SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review, and other communications
Attend and be a contributor at Clinical Study Team Meetings
Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review
Initiate cross-functional team meetings as necessary (e.g., SAP review, TFL shell review, TFL review)
Provide statistical guidance, review, and be responsible for statistical analysis of individual studies/projects
Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints (programmatically)
Perform data-driven modeling during clinical studies
Coordinate the creation of required outputs for Dose Level Review Meetings (DLRMs) as well as coordinate and participate in the DLRM
Review TFLs created by statistical programming for consistency and accuracy
Author analysis reports such as Flash Memo, and results section of the CSRs
Collaborate with the study programming team for study deliverables
Manage timelines for all statistics-related deliverables by working with the cross-functional team members (e.g., programmers, study statisticians, clinical data managers, medical writers)
Be familiar with all Company’s policies, SOPs and other controlled documents related to study activities noted above
Assist with study and systems audits conducted by Company GCA and external bodies

Minimum Qualifications:

Master’s degree in Statistics/Biostatistics or other subject with high statistical content with at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research (or PhD degree with at least 3 years experience)
Strong skill in communicating statistical information clearly and concisely (written and oral)
Strong understanding of statistical concepts related to the design and conduct of clinical studies
Strong ability to apply statistical methodologies in the analysis of clinical trials
Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
Previous experience in the development, author, and execution of protocols and SAPs, as well as review of CSRs
Excellent oral and written English communication skills
Strong SAS and/or R programming skills in conducting simulations and applying statistical concepts and methods based on complex study design

Preferred Qualifications:

Master’s degree in Statistics/Biostatistics or other subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics or other subject with high statistical content and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) AND at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
Leadership of at least 3 clinical studies/projects end-to-end with minimal oversight
Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS
Demonstrated ability to influence decision making
Experience in adaptive clinical trials and innovative study designs
Experience in the utilization of Bayesian statistics in clinical trials
Proficient R programming skills conducting simulations and applying statistical concepts and methods based on complex study designs

To apply for this job please visit www.simulstat.com.

To apply for this job please visit www.simulstat.com.

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SimulStat Incorporated

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