Executive Director of Biostatistics
Executive Director of Biostatistics
Overview
Senior leadership role within a late‑stage biotech environment overseeing Biostatistics and Data Management across the clinical portfolio. This individual will lead strategy and execution for data management and statistical activities, manage senior internal leaders, and provide high‑level oversight of external CRO and statistical partners. Strong involvement in clinical development, regulatory readiness, and submission support.
Key Responsibilities
- Executive oversight of Biostatistics and Data Management functions
- Leadership and mentoring of senior Data Management leadership
- Oversight of external CROs, statistical vendors, and consultants
- Statistical planning, analysis, and reporting across clinical trials
- Review and approval of key statistical deliverables and outputs
- Support protocol development, study design, and regulatory submissions
- Ownership of timelines, resourcing, and budgets
- Participation in inspections, audits, and Health Authority interactions
Background
- Advanced degree in Statistics (or related field)
- Extensive experience in clinical development (biotech, pharma, or CRO)
- Senior‑level leadership experience (Senior Director / Executive level)
- Lead statistician experience across multi‑phase trials and submissions
- Strong SAS and CDISC (SDTM / ADaM) expertise
- Deep understanding of regulatory and GCP/ICH requirements
Benefits
- Comprehensive medical, dental, and vision coverage
- Health Savings Account (HSA) and Flexible Spending Accounts (health & dependent care)
- Generous paid time off and paid holidays, including Dec 24 - Jan 1
- Paid parental leave
- 401(k) with a highly competitive employer match
- Life, AD&D, Short‑Term and Long‑Term Disability insurance clinical portfolio
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