Director, Biostatistics

Position Summary

Director of Biostatistics is a member of cross-functional team and contributes to development of compounds within a therapeutic area. 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. Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defenses. Provides guidance and management to statisticians to ensure high quality and timely deliverables. Manages resources, sets priorities, and ensures consistency and adherence to standards therein.

Key Responsibilities

• Drives innovative and efficient study design.
• Develops study designs that address study objectives that will support regulatory approval, medical research and market access.
• Independently leads, initiates, and oversees the statistical support for the development of compounds within a therapeutic area.
• Provides guidance and management to statisticians to ensure high quality and timely deliverables.
• Effectively engages as a matrix team member on high level development teams, to act as a scientific and strategic partner in the drug development process.
• Presents and defends complex statistical solutions to all levels of BMS governance, key stakeholders and external regulatory bodies in a clear, concise, complete, and transparent manner that provide influence on key decisions.
• Contributes to Clinical Development Plans, leads GBDS related submission activities, and post-submission strategies/preparations/defenses.
• Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information.
• 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 creation/maintenance of and provide training on statistical topics departmental SOPs.
• Manages a functional or project budget and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards therein.
• Represents BMS at professional societies, and in industry-wide technical discussions.
• Contributes to the statistical community of practice.
• Provides active coaching to biostatistical team members when developing solutions to problems.
• Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
• Effectively engages as an employee advocate and management coach/mentor to team members both internally and externally.
• Provides leadership to empower and develop the team.
• Provides guidance to employee's development plans and carries out performance review and feedback.
• Develops performance metrics for staff.

Qualifications & Experience

• PhD (9+ years experience) or MS (11+ 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.
• Excellent interpersonal, communication, writing and organizational skills.
• Demonstrate expertise in applying knowledge of general and cutting edge statistical/clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.
• Experience in preparing and participating in global regulatory agency interactions.
• Demonstrate excellent collaboration, organizational/leadership abilities, and interpersonal skills.
• Demonstrate development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area.
• At least 3 years management (direct or matrix) experience is preferred (for people manager position only).