Senior Manager, Biostatistics at Pacira BioSciences in Parsippany, NJ

Job description

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 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. The Manager, Biostatistics is responsible for conducting biostatistical activities to support all phases of clinical development and post-marketing efforts. This role will collaborate closely with other biostatisticians, statistical programmers, and cross-functional team members, as well as with contract research organization (CRO) partners and other vendors to meet company R&D objectives. Individuals in this role will support the development and review of statistical deliverables and provide high-quality analytical outputs to inform clinical and regulatory decision-making. Responsibilities Essential Duties & Responsibilities: Provide statistical leadership for one or more clinical development programs, ensuring consistency and quality of statistical deliverables. Manage statistical responsibilities of clinical studies from program development through CSR creation and publication, collaborating with other statisticians and statistical programmers. Serve as the primary statistical point of contact for assigned programs and studies. Serve as a key contributor to protocol development and study design. Perform sample size calculations. Develop and/or review statistical analysis plans. Contribute to the design and 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. Review and approve statistical deliverables produced internally or by CRO partners, ensuring high quality deliverables and compliance with regulatory standards and company expectations. Manage biostatistics CRO partners, ensuring quality and adherence to SOPs. 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, development of preparation materials and briefing book materials for meetings and communications with regulatory authorities. Interaction: The Manager - Biostatistics will interact with team members from clinical affairs, clinical operations, data management, medical writing, project management, regulatory affairs, and CRO partners. Qualifications 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: Master’s Degree in statistics, biostatistics from accredited college or university Minimum 2 years of experience within the biotech/pharmaceuticals industry or a related