Associate Director, Biostatistics

Associate Director, Biostatistics

BMS - Bristol-Myers Squibb

Warsaw, Poland

Position Summary

The Associate Director of 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 of Biostatistics can have responsibilities for supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the Biostatistics indication/asset Lead, and other cross functional team members.

Key Responsibilities

• Collaborates in 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 protocol, statistical analysis plan, 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 request, publication, presentation, and other public release 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, to act as a scientific and strategic partner in the drug development process
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable
• Contributes to external and internal statistical community of practice
• Develops & advises team members
• Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS
• Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner

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 as it related to clinical development and ability to apply to relevant clinical development framework
• Good understanding of regulatory landscape and experience with participating in regulatory interactions
• Demonstrate collaboration, organizational/ leadership abilities, and interpersonal skills
• Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills
• People manager experience is preferred (for people manager position only)