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.
Education & Experience Requirements:
Bachelor's degree in Statistics/Biostatistics, Computer Science, Mathematics, Epidemiology, Health Economics or related technical discipline required. Master's Degree in Statistics/Biostatistics or related quantitative field preferred. Equivalent combination of education and applicable job experience may be considered.
4+ years of relevant experience in the biopharmaceutical industry or healthcare system required.
Strong understanding of fundamental statistical principles, best practices, and industry standards applicable to HEOR, RWE, and Market Access.
Hands-on experience in extracting, organizing, and analyzing data from SDTM and ADaM datasets, and/or claims databases, electronic medical records, registries, or other epidemiological data sources.
Experience with study designs, power/sample size computations, longitudinal data analysis, survival analysis, cost-effectiveness analysis, statistical modeling, and simulation.
Proficiency in R or SAS programming.
Additional Skills & Experience:
The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
Driven, intelligent, passionate about making a difference for patients with rare diseases
Some experience collaborating with external vendors or CROs.
Working knowledge of the drug development process from early to late stage. Experience in orphan or rare diseases is a plus.
Ability to manage multiple tasks with competing timelines.
Strong communication and collaboration skills; ability to explain statistical concepts to non-statisticians.
Detail-oriented, solution-driven, and able to work effectively in a dynamic environment.
Ability to travel 10% domestically and internationally
All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric,... For full info follow application link.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
