Head of Biometrics

BACK TO JOBS Head of Biometrics APPLY NOW Head of Biometrics Company: Clinical-Stage Biotechnology Company Location: Boston, MA Employment Type: Permanent The Opportunity Brio Resource Group is partnering with a clinical-stage biotechnology company to identify an experienced Head of Biometrics . This senior leadership position will establish and lead the company’s biometrics strategy across Biostatistics, Statistical Programming, and Data Management. The successful candidate will provide strategic and technical direction across the clinical portfolio while building scalable capabilities to support development milestones, regulatory submissions, and continued organizational growth. Key Responsibilities Define and execute the biometrics strategy across clinical development programs. Lead Biostatistics, Statistical Programming, and Clinical Data Management activities. Provide statistical leadership for protocol development, study design, endpoints, sample-size assumptions, analysis plans, and data interpretation. Ensure the quality, integrity, and regulatory compliance of clinical data and statistical deliverables. Oversee external biometrics vendors, CROs, budgets, timelines, and performance. Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Translational Medicine. Lead biometrics contributions to regulatory submissions and interactions with the FDA and other global health authorities. Support clinical-development plans, go/no-go decisions, publications, scientific presentations, and executive-level portfolio reviews. Establish biometrics processes, standards, systems, and governance appropriate for a growing biotechnology organization. Build, mentor, and develop a high-performing internal biometrics team as organizational needs evolve. Qualifications Advanced degree in Biostatistics, Statistics, Mathematics, or a closely related discipline; a PhD is strongly preferred. Significant biometrics leadership experience within biotechnology or pharmaceuticals. Demonstrated experience supporting clinical programs from early development through pivotal studies and regulatory submissions. Deep expertise in clinical-trial design, statistical methodology, data analysis, and regulatory expectations. Experience overseeing Biostatistics, Statistical Programming, and Clinical Data Management functions. Successful record of leading CROs, external vendors, and internal cross-functional teams. Direct experience contributing to FDA and other global regulatory interactions and submission activities. Strong leadership, communication, and organizational-development capabilities. Ability to operate strategically while remaining technically engaged within a lean, fast-moving clinical-stage environment. Why Consider This Opportunity? This role offers the chance to shape the biometrics function at a critical stage of company growth, influence clinical and regulatory strategy across the portfolio, and build the team and infrastructure needed to advance innovative therapies to patients.