Our client is a clinical-stage biotechnology company entering an exciting phase of growth as it prepares to advance multiple clinical programs into late-stage development. They are seeking an accomplished Vice President, Biometrics to provide executive leadership across Biostatistics, Statistical Programming, and strategic biometrics initiatives.

Reporting to senior Research & Development leadership, this executive will define and execute the company's integrated biometrics strategy while serving as a key partner across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Drug Safety, and Data Management.

This is a highly visible leadership opportunity for an experienced biometrics executive who enjoys building strategy while remaining actively engaged in the scientific and operational execution of clinical programs.

Key Responsibilities

Executive Biometrics Leadership

• Develop and execute the company's integrated biometrics strategy supporting late-stage clinical development and future pipeline expansion.
• Provide executive leadership across Biostatistics, Statistical Programming, and external biometrics partnerships.
• Serve as a key member of the Clinical Development Leadership Team, contributing to program strategy and corporate objectives.
• Establish scalable biometrics processes, governance, standards, and operating procedures to support continued organizational growth.
• Build and develop internal biometrics capabilities as the organization evolves.

Clinical Development Strategy

• Lead biometrics strategy across multiple clinical development programs, with primary responsibility for pivotal and late-stage clinical trials.
• Provide strategic guidance on study design, endpoint selection, statistical methodology, sample size determination, and innovative clinical trial approaches.
• Ensure statistical rigor and scientific integrity throughout all phases of clinical development.
• Partner closely with cross-functional leaders to support efficient study execution and data-driven decision-making.

Regulatory Leadership

• Support global regulatory submissions and health authority interactions.
• Contribute to briefing documents, regulatory responses, statistical analyses, and submission strategies.
• Ensure compliance with ICH-GCP guidelines and global regulatory expectations.
• Provide strategic input into inspection readiness and overall regulatory planning.

Vendor & CRO Oversight

• Lead oversight of CROs and external biometrics vendors responsible for:
• Biostatistics
• Statistical Programming
• Data Management
• Biometrics-related deliverables
• Establish governance processes to monitor vendor performance, quality, timelines, and budgets.
• Build collaborative partnerships while ensuring accountability and operational excellence.

Statistical & Data Oversight

• Oversee development, review, and approval of key biometrics deliverables including:
• Statistical Analysis Plans (SAPs)
• Data Management Plans (DMPs)
• Case Report Forms (CRFs)
• Tables, Figures & Listings (TFLs)
• Interim Analyses
• Database Locks
• Clinical Study Reports
• Ensure the highest standards of data quality, integrity, and statistical excellence across all development programs.

Qualifications

Required

• Bachelor's degree required; advanced degree (MS or PhD) in Biostatistics, Statistics, Mathematics, or related quantitative discipline strongly preferred.
• 12+ years of progressive biometrics experience within the biotechnology or pharmaceutical industry.
• Significant experience leading biometrics strategy for late-stage clinical development programs.
• Demonstrated success supporting Phase III clinical trials and global regulatory submissions.
• Proven experience managing CROs and external biometrics vendors.
• Deep understanding of statistical methodology, clinical trial design, regulatory expectations, and global development practices.
• Strong executive presence with the ability to communicate complex statistical concepts to technical and non-technical audiences.
• Demonstrated ability to balance strategic leadership with hands-on problem-solving in a dynamic biotechnology environment.
• Excellent collaboration, communication, and leadership skills.

Preferred

• Experience leading interactions with FDA and other global regulatory agencies.
• Background supporting cardiovascular, rare disease, genetically defined conditions, or other complex therapeutic areas.
• Prior experience within emerging or mid-sized biotechnology companies transitioning into pivotal-stage development.
• Experience building or scaling biometrics organizations and operational infrastructure.
• Familiarity with adaptive trial designs, Bayesian methodologies, decentralized trials, and other innovative statistical approaches.