Senior Manager, Biostatistics

Pacira Pharmaceuticals, Inc.

4d•Onsite

About The Position

The Senior Manager, Biostatistics will contribute to multiple biostatistical activities for the company, supporting all phases of clinical development and post‑marketing 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.

Requirements

Ph.D. in biostatistics or statistics with at least 4 years, 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.
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.

Nice To Haves

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.

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.