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.
* Recognized expert status – internally and/or externally within the biostatistics/pharma community
* Novel problem‑solving – leading high‑risk, high‑complexity projects requiring development of new statistical methodologies
* Strategic contribution – input into sub‑function or therapeutic area statistical strategy
* People leadership – formal management of a senior team with accountability for performance and resources
* Industry influence – thought leadership through publications, regulatory advisory panels, or shaping industry best practices
Key Responsibilities
* Contributes to preparation of the development strategy that will allow for effective and safe utilisation 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 through external interactions via collaborations with alliance partners, academic and government research organisations 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.
* Compliant with BMS processes and SOPs, global and project standards, and responsible for 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 organisational skills
* Expertise in statistical/clinical trials methodology and ability to apply to relevant framework
* Good understanding of regulatory & HTA landscape and relevant experience
* Demonstrate collaboration, organisational/leadership abilities, and interpersonal skills
* Demonstrate ability to plan, organise, and prioritise multiple work assignments, and strong project management skills
Occupancy and Work Environment
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site‑essential, site‑by‑design, field‑based and remote‑by‑design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.
* Site‑essential roles require 100% of shifts onsite at your assigned facility.
* Site‑by‑design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity and a positive company culture.
* For field‑based and remote‑by‑design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People With Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
R1601178 : Associate Director, Biostatistics
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