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Department: 106300 Biometrics Location: 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. Position Summary: The Associate Director, Biostatistics will work closely with the Biometrics Team Lead in providing statistical support to clinical studies, commercial or development programs. This role oversees statistical aspects of assigned studies or projects to ensure that scientific, regulatory, quality, and commercial requirements are met and that plans are aligned with development goals. The incumbent 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, 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 could also serve as the Biometrics team lead for a project. Responsibilities: Represent the statistics function and provide statistical leadership in support of clinical studies or projects, including post-approval studies. 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 DB specifications, validation plans, TFLs, reporting and analysis datasets 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. Education/Experience Requirements: M.S. in Statistics/Biostatistics is required, Ph.D. is preferred. Equivalent combination of education and applicable job experience may be considered. Minimum 6 years of relevant experience in the biopharmaceutical industry. Hands-on experience in all tasks of a Study Statistician (a