
Senior Biostatistician
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Job overview
The Senior Biostatistician provides statistical support for Health Economics and Outcomes Research, Real World Evidence, and Market Access activities related to drug development and commercialization. Working under Biostatistics leadership, the role contributes to study design, analysis, reporting, and interpretation, and collaborates with cross-functional teams, vendors, programming, and data management to coordinate and review study deliverables.
Full job description
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 Senior Biostatistician will work under the general direction of the Associate Director, Biostatistics in providing statistical support to Health Economics and Outcomes Research (HEOR), Real World Evidence (RWE), and Market Access activities in support of drug development and commercialization. This role contributes to statistical aspects of assigned studies or projects to ensure that scientific, regulatory, and quality requirements are met and that plans are aligned with development and commercialization goals. The incumbent will provide statistical knowledge in study design, statistical analysis, reporting, and interpretation of data. The Senior Biostatistician will provide hands-on statistical support to project teams by conducting statistical analyses, collaborating with external vendors, and working closely with programming and data management to plan, organize, coordinate, and review Biometrics deliverables for assigned studies/projects. The incumbent will collaborate with cross-functional teams composed of internal and/or external experts. Responsibilities: Provide statistical support to clinical studies or projects under the guidance of senior Biostatistics leadership. Collaborate with cross-functional teams in support of HEOR, RWE, and Market Access activities. Contribute to the planning and execution of analyses of clinical trial data, claims databases, electronic medical records, disease registries, or other epidemiological data sources in coordination with the HEOR/RWE, Market Access, and Biometrics teams. Work directly with study/project teams to identify statistical issues and propose appropriate solutions. Provide statistical input to study reports, value/reimbursement dossiers, publications, and other internal or external data requests. Perform statistical modeling and analyses as needed. Prepare and review analysis plans, case report forms, database specifications, validation plans, TFL shells, analysis datasets specifications, and supporting documentation for observational studies or clinical trials. Review analytical work conducted by colleagues, external collaborators, or third-party service providers and escalate issues as appropriate. Collaborate with internal and/or external Biometrics teams to support timely and high-quality study/project deliverables. Contribute to the development and refinement of Biometrics-related SOPs, work practice documents, and technical standards. Apply established statistical methodologies to transform data into actionable insights to support decision making. Additional duties assigned as needed.
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