Director, Biostatistics

About This Role

This Director of Biostatistics role involves leading the statistical aspects of drug development within a therapeutic area. The position focuses on designing innovative and efficient clinical trials, contributing to regulatory submissions, and providing guidance to other statisticians. It suits a professional who can act as a scientific and strategic partner in the drug development process and effectively communicate complex statistical solutions.

Responsibilities

• Drive innovative and efficient study design
• Develop study designs that address study objectives to support regulatory approval, medical research, and market access
• Independently lead, initiate, and oversee statistical support for the development of compounds within a therapeutic area
• Provide guidance and management to statisticians to ensure high quality and timely deliverables
• Effectively engage as a matrix team member on high-level development teams, acting as a scientific and strategic partner in the drug development process
• Present and defend complex statistical solutions to all levels of BMS governance, key stakeholders, and external regulatory bodies in a clear, concise, complete, and transparent manner that influences key decisions
• Contribute to Clinical Development Plans, lead GBDS-related submission activities, and post-submission strategies/preparations/defenses
• Provide statistical support and leadership to address health authority requests, publications, presentations, and other public release of information
• Comply with BMS processes and SOPs, adhere to global and project standards within an indication or therapeutic area, and be responsible for the quality of deliverables
• Contribute to the creation/maintenance of and provide training on statistical topics and departmental SOPs
• Manage a functional or project budget and allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards
• Represent BMS at professional societies and in industry-wide technical discussions
• Contribute to the statistical community of practice
• Provide active coaching to biostatistical team members when developing solutions to problems
• Effectively communicate the GBDS Mission and Vision in a fashion that generates pride, excitement, and commitment within GBDS
• Effectively engage as an employee advocate and management coach/mentor to team members

About the Company

Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. The company focuses on oncology, hematology, cell therapy, immunology, cardiovascular, and neuroscience diseases, with one of the most promising pipelines in the industry.