Senior Director, Biometrics

Overview

At Pacira, innovation meets purpose.

Pacira Bio Sciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we're building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what's possible in pain management-and we can't do it without talented people like you.

Why Join Us?

At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere.

Summary:

The Sr. Director/Executive Director, 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.

Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

Biometrics Leadership & Strategy

• 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.

Study Design, Analysis & Interpretation

• Provide statistical leadership for clinical trials across Phase 1-4 (as applicable), including endpoint selection, sample size justification, and analysis strategies.
• 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.

Biometrics Deliverables & Submission Support

• 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.

Vendor Oversight & Operational Execution

• 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.

Quality, Compliance & Inspection Readiness

• 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.

Cross-Functional Collaboration & Influence

• 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.

Capability Building & Continuous Improvement

• 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.

Supervisory Responsibilities

• This position will have supervisory responsibilities leading the internal team and managing deliverables from external vendors/consultants.

Education and Experience:

• Advanced degree in Biostatistics, Statistics, Mathematics, or a related quantitative field (PhD preferred; MS with significant experience considered).
• 12+ years of experience in biometrics/biostatistics within biotech/pharma or related field, including leadership responsibility on…