Executive Director, Biostatistics - Medical Affairs

Executive Director of Biostatistics (Medical Affairs)
Responsibilities

• Provide statistical oversight for biostatisticians supporting Medical Affairs and biostatistics work by internal biostatisticians and external consultants.
• Provide strategic statistical input for Medical Affairs studies, observational studies, and broader evidence-generation activities (with RWE and HEOR).
• Oversee completion of technical and operational statistical activities by managing internal and external resources.
• Build, develop, and lead the Medical Affairs Biostatistics team (structure, staffing plans, capability development, operating model).
• Anticipate emerging projects; develop staffing plans and assign/managing resources by priorities and strategy.
• Negotiate project timelines across programs and coordinate limited resources to deliver quality work on time.
• Develop and ensure adherence to SOPs, BEDs, and departmental standards for methodology, data analysis, and interpretation.
• Champion decision-enabled statistical tools and explore more efficient/innovative approaches.
• Ensure scientific integrity and maintain rigorous statistical standards.
• Participate in cross-functional leadership meetings and represent Biostatistics.

• Excellent verbal/written communication; negotiation and interpersonal skills.
• In-depth drug development knowledge; strong commitment to GCP, ICH guidelines, and regulatory requirements.
• Ability to supervise team leads; delegate, coach, and provide career development.
• Strong judgment/problem-solving; evidence-based decisions with limited information.
• Preferred: experience in Medical Affairs, observational studies, and/or broader evidence generation.

• PhD and 12 years’ experience.

• PhD in Biostatistics (or equivalent) and 16+ years industry experience.

• Create Inclusion;
  Develop Talent;
  Empower Teams.