Vice President – Head of Biometrics

Role Overview

• Provide strategic and operational leadership for the entire Biometrics organization, including Biostatistics, Statistical Programming, and Data Management across all clinical development programs, with primary focus on Phase III execution
• Build, mentor, and lead internal biostatistics capabilities over time, as appropriate to company growth
• Define and execute an integrated biometrics strategy across all clinical development programs from Phase 2 through registration
• Define and implement an integrated biometrics strategy supporting clinical trial design, data quality, statistical analysis, and regulatory submissions
• Serve as a core member of the clinical leadership team, partnering closely with Clinical Operations, Data Management, Regulatory Affairs, Safety, and Medical Affairs to proactively identify risks and support development decisions
• Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities
• Drive organizational planning, hiring, mentoring, succession planning, and capability development across the Biometrics function
• Oversee development and review of key deliverables including SAPs, DMPs, CRFs, TFL shells, interim analyses, database locks, and clinical study reports
• Ensure data integrity, statistical rigor, and compliance with GCP, ICH, and global regulatory requirements
• Provide strategic input into study design, endpoint selection, sample size calculations, and adaptive or innovative trial methodologies as appropriate
• Support regulatory interactions and submissions, including briefing documents, responses to health authority questions, and advisory committee preparations
• Establish scalable biometrics processes, standards, and SOPs to support late-stage development and future pipeline growth

Requirements

• Bachelor’s degree or advanced degree, ideally in biostatistics, statistics, mathematics, or a related quantitative discipline
• Minimum of 12 years of progressive experience in biostatistics within the biotechnology or pharmaceutical industry
• Experience leading multidisciplinary Biometrics organizations encompassing Biostatistics, Statistical Programming, and Data Management
• Demonstrated success building, mentoring, and developing high-performing biometrics teams in a growing biotechnology organization
• Significant experience leading biostatistics activities for Phase III clinical trials and regulatory submissions
• Demonstrated success managing CROs and external vendors in a late-stage development environment
• Proven track record as a strategic biometrics leader, contributing substantively to complex study designs, endpoint development, and statistical strategy across global development programs; able to provide sharp, on-your-feet thinking in real-time discussions with regulators, KOLs, and cross-functional teams, while maintaining a roll-up-your-sleeves approach to engage directly with protocols, analysis plans, and data when needed.
• Strong understanding of global regulatory expectations related to clinical data, statistical analyses, and inspection readiness
• Proven ability to operate strategically while remaining hands-on in a lean organization
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude.

Tech Stack

• Google Cloud Platform

Benefits

• competitive total rewards package, including an annual bonus
• equity
• comprehensive benefits offering