Senior Director - Head of Biometrics

Senior Director Biostatistics- Head of Biometrics

Hybrid: New Jersey

Role Summary

The Senior Director Biostatistics - Head of Biometrics will serve as the organization's most senior biometrics leader, providing both strategic direction and hands‑on leadership across biostatistics and statistical programming to support clinical development and global regulatory submissions.

This role is accountable for biometrics strategy, high‑quality deliverables, vendor oversight, and inspection readiness, while partnering closely with cross‑functional leaders to enable data‑driven decision‑making across a growing clinical portfolio. The successful candidate will build scalable biometrics infrastructure and help shape development strategy in a fast‑paced, innovative biopharma environment.

Key Responsibilities

Biometrics Leadership & Strategy

• Lead the biometrics function, setting strategic direction across biostatistics and statistical programming.
• Serve as a trusted advisor to senior leadership and the primary biometrics voice across program teams.
• Establish fit‑for‑purpose biometrics processes, standards, and governance aligned with portfolio growth.
• Own biometrics budgets, contracts, and resource planning.

Study Design, Analysis & Interpretation

• Provide statistical leadership across clinical trials (Phase 1-4, as applicable), including endpoint selection, sample size estimation, and analysis strategies.
• Author and review biometrics deliverables such as SAPs, statistical sections of protocols, randomization plans, interim analysis approaches, and final analyses.
• Ensure clear interpretation and communication of results to guide internal decisions and external disclosures.

Biometrics Deliverables & Submission Support

• Accountable for the timely,high‑quality delivery of:
  • CDISC‑compliant datasets (SDTM/ADaM) and define.xml
  • Tables, Figures, and Listings (TFLs)
  • Clinical Study Reports (CSRs), briefing books, and integrated summaries (ISS/ISE), as needed
• Ensure biometrics outputs meet regulatory expectations and support global submissions (FDA, EMA, and other agencies).
• Lead biometrics input into regulatory interactions, including meeting preparation and response strategy.

Vendor Oversight & Operational Execution

• Define and execute the biometrics outsourcing strategy, overseeing CROs and external vendors.
• Establish scopes of work, KPIs, governance models, and quality oversight to ensure predictable execution.
• Develop and manage biometrics budgets, forecasts, and capacity plans aligned to portfolio priorities.

Quality, Compliance & Inspection Readiness

• Ensure biometrics activities are audit‑ and inspection‑ready, with strong documentation and traceability.
• Maintain compliance with applicable regulations and standards (e.g., ICH E9/E3, CDISC, 21 CFR Part 11).
• Proactively identify and mitigate biometrics risks, escalating issues with proposed solutions.

Cross‑Functional Collaboration & Influence

• Partner closely with Clinical Development, Clinical Operations, Data Management, Medical Writing, Regulatory Affairs, QA, and HEOR.
• Drive alignment on data standards, database lock readiness, and reporting timelines.
• Communicate biometrics strategy and insights clearly to senior stakeholders.

Capability Building & Continuous Improvement

• Build scalable biometrics infrastructure, including templates, programming standards, and reusable code.
• Improve efficiency through process optimization, automation, and fit‑for‑purpose analytics.
• Support hiring, mentoring, and development of biometrics talent as the organization grows.

Supervisory Responsibilities

• Lead internal biometrics resources and oversee deliverables from external vendors and consultants.

Qualifications

Education & Experience

• Advanced degree in Biostatistics, Statistics, Mathematics, or a related quantitative field (PhD)
• 12+ years of experience in biometrics/biostatistics within biotech, pharma, or a related environment, including leadership accountability for clinical programs.
• Demonstrated ability to independently program in SAS and/or R in support of clinical and statistical objectives.
• Deep expertise in clinical trial statistics and regulatory deliverables.
• Strong working knowledge of CDISC standards (SDTM, ADaM, CDASH).
• Proven experience managing CROs, vendors, and consultants with successful on‑time delivery.
• Experience supporting NDA, BLA, and/or MAA submissions and regulatory interactions.
• Familiarity with modern analytics approaches that improve efficiency and quality.

Leadership Attributes

• Strategic thinker with a strong execution mindset; comfortable being hands‑on when needed
• High scientific rigor and sound judgment
• Thrives in lean, fast‑moving organizations
• Strong ownership mentality with the ability to build function and infrastructure
• Collaborative leader who can influence without relying on hierarchy

Salary: 240-270.000 base salary + bonus + equity + benefits