Associate Director, Biostatistics

Department

106300 Biometrics

San Diego, USA
- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast‑paced environment and share in our mission – to identify, develop and deliver life‑changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

The Associate Director, Biostatistics will work closely with the Biometrics Project Lead in providing statistical support to clinical studies, commercial or development programs. This role will serve as the lead statistician of late‑stage trials and independently drive statistical strategy & execution. This role oversees statistical aspects of these trials to ensure that scientific, regulatory, quality, and commercial requirements are met and that plans are aligned with development goals & timelines.

The Associate Director will provide statistical knowledge in study design, statistical analysis, reporting, and interpretation of data. This role will provide hands‑on support to project teams by conducting statistical analysis, overseeing external vendors (including Biostatistics and Programming vendors), and working closely with programming and data management to plan, organize, coordinate, review, and ensure timeliness and quality of Biometrics deliverables for assigned studies/projects.

The incumbent will collaborate with cross‑functional teams composed of internal and/or external experts and will serve as the Biometrics study lead within a broader development program, with accountability for day‑to‑day statistical execution and study deliverables, escalating program‑level issues as appropriate.

• Represent the statistics function and provide statistical leadership in support of clinical studies or projects, including post‑approval studies. Independently drive statistical decisions, deliverables, and timelines in collaboration with the cross‑functional study team.
• Contribute to the planning and lead the delivery of the statistical components to support the analysis and reporting needs of clinical studies/projects. Work directly with study/project teams to identify statistical issues, and to propose and implement solutions.
• Conduct ad hoc and exploratory analyses to support Medical Affairs and commercial needs, including review of abstracts and manuscripts for publications and presentations.
• Provide statistical input to study reports, regulatory documents, publications, and other internal or external data requests. Perform statistical modeling and analyses as needed.
• Prepare, review and/or approve SAPs, case report forms, clinical database specifications, validation plans, TFLs, reporting and analysis dataset specifications, and supporting documentation.
• Provide statistical oversight to internal and/or external Biometrics teams to ensure timeliness and quality of study/project deliverables.
• Contribute to the development and maintenance of Biometrics‑related SOPs, work practice documents, technical standards, and specification documents.
• Research and apply new statistical approaches as needed. Develop new or leverage existing statistical methodologies to convert data into information to enable decision making.

• M.S. in Statistics/Biostatistics is required, Ph.D. is preferred. Equivalent combination of education and applicable job…