Head of Biometrics

Our Watertown based client is seeking a VP level Head of Biometrics to lead biostatistics and statistical programming across clinical and translational development. This role owns statistical strategy, clinical trial design, analysis planning, and delivery of high‑quality data outputs that support decision‑making, publications, and regulatory submissions. You’ll partner closely with clinical, data management, translational sciences, and regulatory teams to drive rigorous, data‑driven development.

Key Responsibilities

• Lead statistical strategy from study design through regulatory submission.
• Provide expertise in protocol design, randomization, sample size, and SAP development.
• Oversee statistical deliverables including SAPs, TFLs, integrated summaries, and exploratory analyses.
• Serve as the statistical lead in regulatory interactions and ensure global compliance (FDA, EMA, ICH).
• Manage statistical programming and ensure high‑quality datasets and analysis outputs.
• Build and lead a high‑performing biometrics team; manage CROs and external partners.
• Support biomarker strategy and exploratory data analyses for target engagement and patient selection.
• Establish SOPs, data governance practices, and contribute to broader data strategy.

Required Qualifications

• Advanced degree in Biostatistics, Statistics, Mathematics, or related field
• PhD + 10+ years industry experience
• MS + 15+ years industry experience
• Proven leadership in biostatistics/biometrics within biotech or pharma.
• Strong knowledge of statistical methods, clinical trial design, and regulatory requirements.
• Oncology development experience strongly preferred.
• Experience managing vendors and building biometrics infrastructure.
• Excellent communication skills and ability to translate complex statistical concepts.
• Strategic, detail‑oriented, and committed to scientific rigor.