Executive Director, Head of Biometrics

Pacira Pharmaceuticals, Inc.•Parsippany-Troy Hills, NJ

1d•Onsite

About The Position

The Executive Director, Head of Biometrics, will serve as the company’s biometrics leader, providing strategic and hands-on leadership across biostatistics and statistical programming to support clinical development and regulatory submissions. This role is accountable for biometrics strategy, high-quality deliverables, and effective vendor oversight, while partnering cross-functionally to ensure data-driven decision-making across the portfolio. As the most senior biometrics leader, this individual will build scalable processes, ensure inspection readiness, and drive execution excellence in a fast-paced, innovative biopharma environment.

Requirements

Advanced degree in Biostatistics, Statistics, Mathematics, or a related quantitative field (PhD preferred; MS with significant experience considered).
15+ years of experience in biometrics/biostatistics within biotech/pharma or related field, including senior leadership responsibility on clinical programs.
Proven ability to independently write SAS and R programs in adherence to clinical and statistical objectives.
Demonstrated expertise leading a biometrics function, including setting strategy, building teams, establishing operating models, and influencing development strategy at the program and portfolio level.
Strong working knowledge of CDISC standards (SDTM/ADaM/CDASH) and clinical reporting expectations.
Proven experience with CROs/vendors/consultants and delivering high-quality outputs on time.
Strong communication and leadership skills with the ability to influence cross-functional stakeholders.
Experience leading biometrics strategy and content for NDA/BLA/MAA submissions, including direct participation in regulatory interactions.
Deep expertise in advanced statistical methods for clinical development, including adaptive designs, estimands, missing data strategies, and longitudinal and time‑to‑event analyses.
Strategic thinker with strong execution focus (“hands-on leader”)
Scientific rigor and sound judgment
Comfortable operating in a lean, fast-moving environment
Strong ownership mindset and ability to lead without extensive infrastructure
Collaborative partner who can align stakeholders and drive decisions

Responsibilities

Lead the biometrics function, providing strategic direction across biostatistics and statistical programming for the clinical portfolio.
Serve as a key advisor to leadership and oversee the primary biometrics representative on program teams.
Establish fit-for-purpose biometrics processes, standards, and governance to support a growing pipeline.
Manage department budget, contracts and resources.
Provide statistical leadership for clinical trials across Phase 1–4 (as applicable), including endpoint selection, sample size justification, and analysis strategies.
Develop simulations of trial operating characteristics to evaluate design options, interim decision rules, and success criteria, enabling data‑driven selection of optimal trial designs.
Author/review key biometrics documents including SAPs, statistical sections of protocols, randomization strategies, interim analysis plans, and final analysis documentation.
Ensure clear interpretation and communication of results to inform internal decisions and external disclosures.
Accountable for 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 contributions meet regulatory expectations and support global submissions (FDA/EMA and other agencies).
Lead biometrics input for regulatory interactions, including meeting preparation and response strategy.
Manage biometrics outsourcing strategy and day-to-day oversight of CROs and vendors to ensure quality, timelines, and cost control.
Define deliverables, scope of work, KPIs, and governance to drive predictable execution.
Develop and manage biometrics budgets, forecasts, and resource plans aligned to portfolio priorities.
Ensure biometrics work is audit- and inspection-ready, with strong documentation, traceability, and quality controls.
Maintain compliance with relevant guidance and standards (e.g., ICH E9/E3, CDISC, 21 CFR Part 11, as applicable).
Identify and mitigate biometrics risks early, escalating issues proactively with solutions.
Partner closely with Clinical Development and Operations, Clinical Affairs, Data Management, Medical Writing, Regulatory Affairs, QA, and HEOR.
Drive alignment on data standards, database lock readiness, and reporting timelines.
Communicate biometrics strategy and results clearly to senior leadership.
Build scalable biometrics infrastructure, including templates, programming standards, and reusable code libraries.
Drive efficiency through process improvement, automation, and fit-for-purpose analytics.
Support hiring, mentoring, and development of biometrics talent as the organization grows.
This position will have supervisory responsibilities leading the internal team and managing deliverables from external vendors/consultants.