Associate Director, Biostatistics
Position Summary
The Associate Director, Biostatistics is a member of cross‑functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, the Associate Director can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBDS Biostatistics Lead, GBDS medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.
Key Responsibilities
* Contributes to the preparation of the development strategy that will allow for effective and safe utilization of the product.
* Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
* Translates scientific questions into statistical terms and statistical concepts into lay terms.
* Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis.
* Communicates effectively with clinical and regulatory partners and external opinion leaders.
* Builds the external reputation of BMS via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation.
* Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case‑report forms, clinical study reports, associated publications and other study level specification documents.
* Exercises cost‑disciplined science in sizing of the trials and in the planning for the analyses to be conducted.
* Complies with BMS processes and SOPs, global and project standards, and is responsible for the quality of statistical deliverables, e.g., tables, listings, and figures.
* Takes accountability for ensuring quality in all planning, design and execution of the assigned protocol or project.
* Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles.
* Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
* Drives alignment at team level and escalates lack of team alignment to the GBDS Lead for resolution.
* Provides statistical consultation for ad hoc analysis requests, including design of appropriate analyses to answer relevant questions.
* Keeps up to date with state‑of‑the‑art applied statistical methodology.
Qualifications & Experience
* PhD (6+ years’ experience) or MS (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry, or healthcare experience.
* Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
* Great interpersonal, communication, writing and organizational skills.
* Expertise in statistical/clinical trials methodology and ability to apply it to the relevant framework.
* Good understanding of regulatory & HTA landscape and relevant experience.
* Demonstrates collaboration, organizational/leadership abilities, and interpersonal skills.
* Demonstrates ability to plan, organize and prioritize multiple work assignments, and strong project management skills.
Bristol Myers Squibb is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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