Executive Director, Biostatistics - Medical Affairs

Executive Director of Biostatistics (Medical Affairs) — Reporting to the Head of Biometrics, leads the Biostatistics function for Medical Affairs studies across all therapeutic areas, building, scaling, and leading a high-performing team.

Responsibilities:
- Provide statistical oversight for Medical Affairs biostatisticians and biostatistics work by internal staff and external consultants.
- Provide strategic statistical input for Medical Affairs studies, observational studies, and evidence-generation activities (with RWE/HEOR).
- Oversee completion of technical/operational statistical activities via internal/external resourcing.
- Build, develop, and lead the Medical Affairs Biostatistics team (structure, staffing plans, capability development, operating model).
- Anticipate emerging projects; develop staffing plans and assign/manage resources by priorities.
- Negotiate timelines across programs; coordinate limited resources to deliver quality work on schedule.
- Ensure adherence to SOPs, BEDs, and standards for Medical Affairs statistical methodology, data analysis, and interpretation.
- Develop/training decision-enabled statistical tools; pursue efficient/innovative statistical approaches.
- Maintain scientific integrity and rigorous statistical standards.
- Represent Biostatistics in cross-functional leadership meetings.
- Provide expectation clarity, delegation/decision-making/communication framework, and constructive feedback.
- Develop talent action plans for retention; identify capability gaps and bridge them.
- Coordinate managerial activities with Biometrics leadership; support compliance risk management and audit/inspection readiness.

Capabilities & Skills:
- Strong communication, negotiation, and interpersonal skills.
- In-depth drug development knowledge; commitment to GCP, ICH, and regulatory requirements.
- People leadership: supervise leads; delegate, coach, provide feedback and career development.
- Strong judgment and evidence-based problem-solving in complex situations.
- Lead strategic initiatives; assess/process improvement; drive change.
- Advise/influence senior leadership on biostatistics strategy; use competitive intelligence.
- Experience in Medical Affairs and/or observational studies/evidence generation (preferred).

Qualifications:
- Required: PhD and 12 years’ experience.
- Preferred: PhD in Biostatistics or equivalent; 16+ years industry experience.

Application:
- Apply via the Internal Career Opportunities portal in Workday.