Executive Director – Biostatistics, Data Sciences
Location
United States
Posted
100 days ago
Salary
$276.8K - $319.1K / year
Seniority
Lead
Job Description
Executive Director – Biostatistics, Data Sciences
BBOT
• lead the biostatistics, data management, and statistical programming functions across all clinical programs • serve as a core member of the clinical development leadership team, contributing to portfolio strategy, asset prioritization, and program governance • provide statistical leadership for oncology trial design, including adaptive designs, Bayesian approaches, biomarker-driven studies, and complex endpoints (e.g., OS, PFS, ORR, MRD) • guide development strategies from first-in-human through registrational and post-marketing studies • act as the statistical authority in interactions with global regulatory agencies (FDA, EMA, PMDA, etc.) • oversee the statistical and data components of INDs, NDAs, BLAs, MAAs, and responses to regulatory questions • ensure timely, high-quality delivery of statistical analyses, datasets, TFLs, and clinical study reports • oversee CRO and vendor strategy for data management and programming • establish scalable processes, standards, and infrastructure to support a growing oncology pipeline • drive innovation in data review, analytics, and visualization to enable real-time decision-making • build, mentor, and retain a high-performing, multidisciplinary team across biostatistics, data management, and statistical programming • partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Translational Medicine, Medical Affairs, and Commercial teams.
Job Requirements
- PhD (preferred) or MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline
- 15+ years (with PhD) or 18+ years (with MS) of experience in biostatistics within biotech or pharmaceutical development
- significant oncology experience
- prior experience leading biostatistics and/or data sciences functions at the Senior Director, Executive Director, or VP level
- demonstrated success supporting late-stage and registrational oncology trials and regulatory submissions
- strong track record of managing CROs and external partners
- deep knowledge of oncology clinical development, endpoints, and regulatory expectations
- working knowledge of relevant FDA, EU, ICH guidelines and regulations
- expertise in statistical methodologies for complex and innovative trial designs
- excellent strategic thinking on innovative statistical methods and the linkage to business values
- working knowledge of data management and statistical programming best practices, including CDISC standards
- familiarity with modern data platforms, analytics tools, and data visualization approaches
- proven ability to influence at the executive level and communicate complex statistical concepts to non-statistical audiences
- outstanding communication skills (verbal and written)
- collaborative leadership style with strong decision-making and prioritization skills
- experience managing multiple projects and operating effectively in fast-paced, resource-constrained biotech environments.
Benefits
- annual bonus
- stock-based long-term incentives
- medical benefits
- dental benefits
- vision benefits
- retirement plans
- wellness stipend
- flexible time off
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