Associate Statistical Project Leader - Oncology
Associate Statistical Project Leader - Oncology
Cambridge, Massachusetts, , Bridgewater, New Jersey
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Lead one or several studies in Oncology Therapeutic Area, under minimum supervision of statistical project leader and/or team leader.
Major Duties and Responsibilities
Provide support and leadership to the clinical trial study and/or project team on all relevant statistical matters:
Provide high quality input into the design of the clinical study (including protocol development) and/or clinical development plan (CDP) for early phase project, the setup and conduct of the study to make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses,
Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., Statistical Analysis plan, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables)
Accountable for statistical aspects of clinical development plan a strategy for standard non-oncology early development projects
Effectively utilize external groups, e.g., CROs or data monitoring committees (DMC).
Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan,
Perform and/or coordinate with study programmer the production of statistical analyses. Review and examine statistical data distributions/properties,
Oversee execution of the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.
Review submission documents, such as IND, NDA, BLA, CTE or cTD to insure statistical validity and accuracy
Contribute to define and review the specific deliverables related to Transparency and Disclosure
Provide technical guidance to junior staff.
Plan and track study/project activities and timelines.
Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation.
Represent statistics to participate in scientific or technology working groups or cross function initiatives; Contribute to operation process optimization and provide inputs to statistics standards.
PhD/MS in statistics or related discipline with at least 3 years of pharmaceutical experience
Good knowledge of pharmaceutical clinical development, together with Late Phase and/or early Phase experience.
Broad knowledge and good understanding of advanced statistical concepts and techniques
Able to work in departmental computing environment, can do advanced statistical analyses using SAS and possibly other languages (R, …)
Demonstrated strong interpersonal and communication skills
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