Overview In this role you lead biostatistics strategy, operations, and personnel to ensure accurate and timely analysis of clinical trial data while upholding data integrity. You shape policy, practices, and SOPs to optimize compliance and efficiency, and contribute to drug development strategy. You collaborate with cross-functional leaders, regulators, and sponsor/CRO partners to drive high-quality statistical support from Phase I-IV. This is an opportunity to influence oncology programs and advance clinical science at a strategic level.
Compensation / Benefits- 401(k) plan with company contributions
- comprehensive medical, dental, and vision coverage
- life and disability insurance
- flexible spending accounts
- discretionary annual bonus program
- stock purchase and long-term incentives
Responsibilities- Develop and implement biostatistics strategies aligned with company objectives
- Manage staffing and resource planning for biostatistics and related tools
- Design and analyze Phase I-IV clinical protocols and statistical analysis plans
- Identify and apply statistical methods for regulatory and publication purposes
- Build relationships with cross-functional leaders in clinical, regulatory, and drug safety
- Represent biostatistics on executive committees and sponsor/CRO governance bodies
- Provide leadership for sponsor/CRO activities and issue escalation
- Ensure SOPs, standards, and workflows improve efficiency, quality, and cost timelines
- Oversee vendor relationships with KOLs, academics, CROs
- Lead Real World Data access and analysis strategies
- Establish and maintain the statistical science and methodological team
- Manage department and CRO budgets within corporate targets
Key requirements- PhD strongly preferred; otherwise PhD-equivalent with extensive biostatistics leadership experience
- Minimum 17-21 years of relevant pharmaceutical industry experience with progressive management roles
- Deep understanding of biostatistics in oncology and clinical trials (Phase I-III)
- Proven track record of delivering US NDA filings and translating strategy into results
- Experience with FDA/EU regulatory interactions and governance
- Ability to lead cross-functional collaboration and executive-level communication
- Strong strategic vision and ability to drive programs and milestones
- leadership and people management
- cross-functional collaboration
- executive communication
- biostatistics leadership
- statistical methods for clinical trials
- RWD data access and analysis
