Senior Manager, Biostatistics

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 Senior Manager, Biostatistics will contribute to multiple biostatistical activities for the company, supporting all phases of clinical development and postmarketing efforts. This role will collaborate closely with fellow biostatisticians, statistical programmers, cross-functional team members, and contract research organization (CRO) partners to meet company R&D objectives. Individuals in this role will support the development and review of statistical deliverables, contribute to the execution of statistical strategies, and provide high-quality analytical outputs to inform clinical and regulatory decision-making. Responsibilities Provide statistical leadership for one or more clinical development programs, ensuring consistency and quality of statistical deliverables. Serve as a key contributor to protocol development and study design. Prepare statistical analysis plans. Lead the analysis of clinical trial and real-world data to support evidence generation for company products from randomized controlled trials and observational studies. Establish effective collaboration with cross-functional team members, including clinical development, medical affairs, clinical operations, data management, and regulatory affairs. Manage statistical responsibilities of clinical studies from program development through CSR creation and publication, collaborating with other biostatisticians and statistical programmers. Review and approve statistical deliverables produced internally or by CRO partners, ensuring compliance with regulatory standards and company expectations. Partner with clinical and regulatory teams to proactively identify risks and mitigation strategies related to statistical design and analysis. Support interactions with regulatory authorities on statistical topics, including participation in meetings, responses to information requests, and development of briefing book materials. Interaction The Senior Manager, Biostatistics, will interact with team members from clinical affairs, clinical operations, data management, medical writing, project management, regulatory affairs, and CRO partners. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and Experience PhD in biostatistics or statistics with at least 4 years of experience, or Master's degree with at least 6 years of experience within biotech/pharma or related field. Experience leading statistical aspects of the design, analysis, and reporting of clinical trials. Knowledge, Skills, and Abilities Strong understanding of clinical trial design principles, including adaptive designs. Ability to balance scientific rigor with operational and business considerations in a fast-paced development environment. Knowledge and extensive hands-on experience with CDISC methodologies and industry data standards. Demonstrated ability to manage multiple priorities and timelines while delivering high-quality outputs. Excellent ability to communicate complex statistical concepts in non-technical language. Working knowledge of regulatory guidelines and expectations in pharmaceutical development; experience supporting regulatory interactions is a plus. Programming experience in SAS is required; experience in R is strongly desired. Familiarity with real-world evidence and observational research methodologies (e.g., causal inference) is a plus. Prior experience supporting clinical development programs in acute or chronic pain is a plus. Physical Demands While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms, and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Work Environment The work will be in a typical office environment (cubicles, offices, conference rooms, etc.) with heavy computer use. 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 Protection Pet Insurance Fertility and Maternity Assistance 401(k) with company match Flexible Time Off (FTO) and 11 paid holidays Paid Parental Leave Pay Transparency The base pay range for this role is $120,000 to $165,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered. EEO Statement EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose. Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira. #J-18808-Ljbffr