Executive Director, Head of Biometrics

Overview: At Pacira, innovation meets purpose. Pacira BioSciences, 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 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. Responsibilities: 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. • 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. 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. Qualifications: Education and Experience: • 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. Competencies & Leadership Attributes: • 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 What Success Looks Like (First 6–12 Months): • Establishes biometrics strategy, operating model, and vendor oversight cadence that supports near-term milestones. • Ensures consistent, high-quality biometrics deliverables across active studies. • Improves predictability of timelines through strong planning and cross-functional alignment. • Builds scalable standards and processes to support pipeline growth and future submissions. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Ability to safely navigate in a traditional office environment, health care facilities, and professional meetings/conferences. • Regularly sit, talk, and move between workspaces. • Maintain close vision and focus on a computer screen for extended periods. • Will travel approximately 10-20%. Benefits: • Medical, Prescription, Dental, Vision Coverage • Flexible Spending Account & Health Savings Account with Company match • Employee Assistance Program • Mental Health Resources • Disability Coverage • Life insurance • Critical Illness and Accident Insurance • Legal and Identity Theft