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About the Role
The Associate Director of Biostatistics is a key member of cross-functional Development teams, contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. This role supports a specific indication of an asset, fostering collaborative relationships with the Biostatistics indication/asset Lead and other team members.
Responsibilities
- Collaborates in the design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy.
- Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols.
- Independently authors and/or reviews protocols, statistical analysis plans, clinical study reports, associated publications, and other study-level documents.
- Presents summary data and analyses results in a clear, concise, complete, and transparent manner.
- Provides statistical support and leadership to address health authority requests, publications, presentations, and other public releases of information.
- Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area.
- Applies extensive knowledge of statistical/clinical trials methodology as it relates to clinical development.
- Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory, and commercial environments with demonstrated application to study design.
- Effectively engages as a matrix team member on project teams, acting as a scientific and strategic partner in the drug development process.
- Ensures compliance with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area, and is responsible for the quality of deliverables.
- Contributes to the external and internal statistical community of practice.
- Develops and advises team members.
- Effectively communicates the DQS Mission and Vision in a way that generates pride, excitement, and commitment within DQS.
Requirements
- PhD (6+ years’ experience) or MSc (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 as it relates to clinical development and ability to apply to relevant clinical development framework.
- Good understanding of the regulatory landscape and experience with participating in regulatory interactions.
- Demonstrated collaboration, organizational/leadership abilities, and interpersonal skills.
- Demonstrated ability to plan, organize, and prioritize multiple work assignments, and strong project management skills.
Skills
- SAS
- R
- Python
- Statistical analysis
- Data manipulation
- Graphing
- Simulation
- Collaboration
- Communication
- Writing
- Organization
- Project management
Location
- Uxbridge
Work Type
- Hybrid
- Onsite (50%)
Experience Level
- Associate Director
- 6+ years (with PhD)
- 8+ years (with MSc)
Education Level
- PhD
- MSc
Benefits
- Supportive environment
- Inclusion
- Wellbeing
- Flexibility
- Comprehensive benefits
About the Company
- Bristol Myers Squibb's purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases.
- We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
- Our work transforms the lives of patients and the careers of those who do it.
Equal Opportunity
- 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.
- Bristol Myers Squibb is Disability Confident – Employer
- BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
- For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
- For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.
- We will never request payments, financial information, or social security numbers during our application or recruitment process.
- Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.