Executive Director - Head of Biometrics

NJ Location (3x a week)

Salary: 270,000-300,000 base + bonus + equity + additional benefits

Overview

Our client is an innovative, growth-oriented biopharmaceutical organization committed to advancing next-generation therapies in areas of high unmet medical need. With a focus on scientific rigor, patient impact, and operational excellence, the company is building a scalable clinical development engine to support an expanding pipeline.

This is a rare opportunity to join a highly collaborative environment where biometrics plays a central role in shaping development strategy and decision-making.

Position Summary

The Executive Director, Head of Biometrics will serve as the company's senior-most biometrics leader, providing both strategic and hands-on leadership across biostatistics and statistical programming.

This role is accountable for:

• Defining and executing the biometrics strategy across the portfolio
• Delivering high-quality statistical outputs to support clinical development and global regulatory submissions
• Establishing scalable infrastructure, processes, and vendor models

The individual will act as a key strategic advisor to leadership, ensuring data-driven decision-making across programs while driving execution excellence in a fast-paced, innovative environment.

Key Responsibilities

Biometrics Leadership & Strategy

• Lead and shape the biometrics function, providing strategic direction across biostatistics and statistical programming
• Establish fit-for-purpose processes, governance, and operating models to support a growing pipeline
• Serve as a senior advisor to executive leadership on biometrics strategy and program decisions
• Manage departmental budgets, resources, and external partnerships

Clinical Development & Statistical Leadership

• Provide statistical leadership across Phase 1-4 clinical trials
• Drive study design, including endpoint strategy, sample size estimation, and analysis methodologies
• Develop and evaluate innovative trial designs, including simulations and interim decision frameworks
• Author and review key documents (SAPs, protocols, analysis plans, randomization strategies)
• Translate complex data into clear insights to support internal and external decision-making

Regulatory & Submission Excellence

• Oversee delivery of all biometrics outputs, including:
• CDISC-compliant datasets (SDTM, ADaM)
• Tables, figures, and listings (TFLs)
• Clinical Study Reports (CSRs) and integrated summaries (ISS/ISE)
• Ensure readiness for global submissions (FDA, EMA, etc.)
• Lead biometrics strategy and participation in regulatory interactions

Vendor Oversight & Operational Execution

• Define and execute a scalable outsourcing model
• Oversee CROs and external vendors to ensure quality, timelines, and cost control
• Establish KPIs, governance structures, and performance tracking

Quality, Compliance & Inspection Readiness

• Ensure biometrics outputs are audit- and inspection-ready
• Maintain compliance with regulatory standards (e.g., ICH E9/E3, CDISC, 21 CFR Part 11)
• Proactively identify risks and implement mitigation strategies

Cross-Functional Leadership

• Partner with Clinical Development, Clinical Operations, Data Management, Medical Writing, Regulatory Affairs, QA, and HEOR
• Drive alignment on study timelines, data standards, and reporting deliverables
• Communicate biometrics strategy and insights effectively to senior stakeholders

Capability Building & Continuous Improvement

• Build scalable biometrics infrastructure (templates, standards, programming libraries)
• Drive process improvements and automation initiatives
• Support hiring, mentoring, and development of biometrics talent

Qualifications

Education & Experience

• Advanced degree in Biostatistics, Statistics, Mathematics, or related field (PhD preferred)
• 15+ years of experience in biometrics within pharma/biotech
• Demonstrated leadership of a biometrics function, including strategy, team building, and operating model design
• Strong experience supporting regulatory submissions (NDA/BLA/MAA) and interactions with health authorities
• Deep expertise in clinical trial methodology and advanced statistical techniques

Technical Expertise

• Strong knowledge of CDISC standards (SDTM, ADaM, CDASH)
• Proficiency in SAS and/or R programming
• Experience with adaptive designs, estimands, missing data strategies, and longitudinal/time-to-event analyses

Leadership Profile

• Strategic, hands-on leader
• Strong communicator with the ability to influence cross-functional stakeholders
• Comfortable operating in a lean, fast-paced environment
• High ownership mindset with the ability to build without extensive infrastructure
• Collaborative, solutions-oriented approach to decision-making

What Success Looks Like (First 6-12 Months)

• Establishes a scalable biometrics strategy and operating model
• Delivers consistent, high-quality outputs across active studies
• Improves timeline predictability through strong planning and alignment
• Builds foundational processes to support future pipeline growth and submissions