Head of Biometrics

We are partnering with an innovative clinical-stage oncology biotechnology company developing novel therapies for patients with significant unmet medical needs.

About the role

This individual will serve as a key member of the development leadership team, reporting into the CMO, and will be responsible for shaping biometrics strategy, supporting regulatory interactions, and driving data-driven decision-making across the portfolio. This is a unique opportunity to join a growing oncology biotech and build upon a biometrics function that will play a critical role in future clinical and regulatory milestones.

Responsibilities

• Serve as the company's biometrics leader, providing strategic oversight of all Biostatistics and Statistical Programming activities
• Lead biometrics strategy across clinical development programs from early-stage studies through registration-enabling trials
• Provide statistical leadership for study design, endpoint selection, protocol development, sample size determination, and analysis planning
• Oversee the development and review of Statistical Analysis Plans (SAPs)
• Act as the primary statistical representative for FDA, EMA, and other global health authority interactions
• Lead biometrics contributions supporting regulatory submissions, including NDA/BLA filings
• Oversee statistical programming deliverables, including SDTM, ADaM, TLFs, and submission-ready datasets
• Partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, and external vendors
• Present data-driven recommendations to executive leadership and key stakeholders
• Establish biometrics processes, standards, and governance frameworks that support organizational growth
• Build, mentor, and develop a high-performing biometrics team while managing CRO and vendor relationships

Qualifications

• PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline
• 15+ years of experience in biostatistics and/or statistical programming within biotechnology or pharmaceutical development
• Previous experience serving as a senior biometrics leader within a biotech environment
• Deep expertise in oncology clinical development
• Experience supporting NDA and/or BLA submissions and regulatory agency interactions
• Strong knowledge of CDISC standards, GCP, ICH guidelines, and global regulatory requirements
• Proven ability to influence cross-functional strategy and executive-level decision making
• Experience overseeing external CROs and biometrics vendors within a lean, fast-paced environment

Location

San Francisco Bay Area, CA (Hybrid)