Executive Director, Biostatistics - Medical Affairs

About the role

Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Medical Affairs will lead the Biostatistics function for Medical Affairs studies across all therapeutic areas and will be responsible for building, scaling, and leading a high-performing Biostatistics team to support the Medical Affairs portfolio. The ideal candidate will have a proven track record of functional leadership, strategic situational judgment in using both innovative and pragmatic statistics, as well as demonstrated motivation for and excellence in people management and development.

Responsibilities

• Provides statistical oversight of all biostatisticians supporting Medical Affairs and all biostatistics-related work conducted by internal biostatisticians and external consultants.
• Provides strategic statistical input and expertise for Medical Affairs studies, observational studies, and broader evidence-generation activities across the portfolio, in partnership with relevant functions including RWE and HEOR.
• Oversees and contributes to the completion of all technical and operational statistical activities through management of internal and external resources.
• Builds, develops, and leads the Medical Affairs Biostatistics team, including team structure, staffing plans, capability development, and operating model.
• Anticipates emerging projects and works with senior management to develop staffing plans; properly assigns and manages resources according to priorities and business strategies.
• Negotiates project timelines across programs with competing priorities given constraints; manages and coordinates limited resources to produce quality deliverables within timelines.
• Develops and ensures adherence to SOPs, BEDs, and all departmental standards and processes regarding the conduct of Medical Affairs studies, statistical methodology, data analysis, and interpretation.
• Champions the development and training of decision-enabled statistical tools; explores opportunities for more efficient and innovative statistical approaches.
• Ensures the scientific integrity of statistical methods applied to Medical Affairs studies and maintains rigorous statistical standards across the portfolio.
• Encourages and empowers biostatisticians to exercise good judgment, embrace a data-driven approach, and follow best practices and principles to become accountable decision-makers.
• Participates in relevant cross-functional leadership meetings, and represents the Biostatistics function.
• Provides clarity on expectations for biostatisticians supporting Medical Affairs, including delegation, decision-making, and communication framework; provides constant constructive feedback accordingly.
• Develops talent action plans to ensure retention of top talent; anticipates upcoming challenges, identifies potential capability gaps, and utilizes internal and external resources to bridge the gaps.
• Coordinates processes, training, and other managerial activities with Biometrics leadership; assesses and addresses potential compliance risks and ensures audit and inspection readiness, as applicable.
• Expected to provide leadership support beyond the core Medical Affairs portfolio, including additional biostatistics and biometrics priorities as organizational and business needs evolve.

Qualifications

• Basic Qualifications