About this role
Job title: Head of Global Biostatistics & Data Management
About the Role The Head of Global Biostatistics & Data Management (BDM) sets the vision and strategy for the statistical function within R&D. You will build a high-impact statistical practice, motivate and develop the department, and provide strategic inputs across the portfolio from pre-clinical through lifecycle management. You will be accountable for the quality and timeliness of all statistical deliverables, promote innovation, standards, and processes, and oversee external vendors in sponsor partnerships. This role collaborates with cross-functional partners and leads a global Biostatistics organization within the BDM leadership team.
What You'll Do
- Provide oversight of statistical activities regionally and globally, directing trial design, SAPs, ISS/ISEs, analyses, and other deliverables to meet timeline and quality objectives.
- Review and provide strategic input to the entire clinical development portfolio; partner with BDM leadership to enable decision-making and execution.
- Manage external vendors: budget, resources, timelines; develop outsourcing strategy; leverage external statistical experts as appropriate.
- Interact with Health Authorities globally: provide strategic input for submissions, review documents, and represent the function at meetings when needed.
- Develop and implement global statistics strategy, standards, SOPs, and innovation roadmap; monitor compliance and promote automation, AI/ML where relevant.
- Lead and develop a high-performing global Biostatistics organization: talent strategy, performance management, succession planning, capability building, and cross-regional resource optimization.
- Provide regular status updates on projects, metrics, and KPIs to the Head of BDM and the BDM leadership team.
- Mentor and coach regional and ex-US staff; provide functional leadership as needed.
What We're Looking For
- PhD in statistics/biostatistics or equivalent required.
- 15+ years pharmaceutical industry experience including global NDA submissions or equivalent; 10+ years direct management of statistical group.
- Minimum 6 years oncology clinical drug development (Phase 1-4) including at least 2 regulatory submissions.
- Strong expertise across methods including interim analyses, Bayesian methods; experience with AI/ML/automation is a plus.
- Demonstrated leadership in global cross-functional settings; vendor management; strategic thinking and execution.
Nice to Have
- Experience with AI/ML/automation and modern statistical tooling.
- Experience leading global cross-functional teams and interactions with health authorities.
Compensation & Benefits
- Not disclosed in posting.