Associate Director, Late Phase Research Biostatistics

Statistical Leader

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:

Provide leadership and guidance as the lead statistician on a project team. For one or more projects, be accountable for all statistical aspects of late phase clinical studies, including observational and investigational study designs and scientific validity. Act as key statistical function representative within company. In some cases, incumbent could serve as department leader in specific technical area.

Essential Duties & Responsibilities :

• Oversee statistical support to multiple project teams. Collaborate with cross-functional and clinical leads in defining general strategic approach, creating late phase research strategy, and producing individual protocols. Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.
• Conduct statistical analyses, prepare of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries. Review and approve key results memos and statistical conclusions. Provide guidance to the clinical and cross-functional teams regarding conclusions and inferences from the data package. Ensure statistical representation at rcross-functional or external meetings. Completed data package relevant for publication or making key decisions.
  
  Statistical deliverables consistently compliant, in timing and quality, with SOPs and departmental standards.
• Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG). Effect consistency of data collection and analysis across project or area. Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects.
• Plan and track project activities, timelines, and resource use across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation.
• Ensure mentoring and development of staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Manage conflict. Productive work environment, individual growth, development of strong contributors. Staff compliance with SOPs and departmental policies.
• Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance. Procedures and practices meet industry standards and are consistent with internal SOP.
• Serve as departmental representative on division or corporate-wide teams. Advocate application of statistical thinking in decision-making. Work effectively with leaders in other functional areas. Effective corporate use of statistical thinking.

Supervisory Responsibilities:

This position will have supervisory responsibility and may manage 1-3 direct reports.

Interaction:

The incumbent will work closely with clinical research and operation, data management, publication.

Education and Experience:

• Ph.D. or master's degree in Biostatistics or closely related discipline from accredited college or university.
• Minimum 5 years of hands on Biostatistics experience in the Pharmaceutical or Biotech industry;
• Minimum 3 years' experience managing and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees
• Minimum of 3 years of SAS and(or) R programming experience.
• Experiences in medical device and gene therapy not required but highly preferred.

Qualifications:

• Demonstrated leadership, project management, and interpersonal skills
• Excellent written and verbal English communication skills
• Excellent presentation skills to groups of varied size and make up.
• Demonstrated broad knowledge and superior understanding of advanced statistical concepts and techniques
• Demonstrated in-depth understanding of observational study designs, including multivariable modeling longitudinal data analysis and causal inference techniques.
• Proven ability to…