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 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. Responsibilities: 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 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 (at least 4 years) or Lead Statistician (at least 2 years). Experience with late-stage drug development, regulatory submissions, registries, or Health Authority interactions is a plus. Additional Skills/Experience/Requirements: Vendor oversight & management experience. Knowledge of the drug development process, from early to late stage. Experience in orphan or rare diseases is a plus. Understanding of FDA and ICH requirements and industry standards applicable to the design, conduct and analysis of clinical trials, including SDTM, ADaM, and CDISC/eCTD requirements for regulatory submissions. Extensive experience with study designs, power/sample size computations, (longitudinal) data analysis, and simulations. Proficiency in SAS programming to produce ad hoc tables, listings and figures. Experience with other statistical software such as R preferred. Experience with data pooling to support Integrated Summary of Safety (ISS)/Integrated Summary of Efficacy (ISE) and periodic reports. Experience working with Medical Affairs to develop abstracts and perform appropriate analyses suitable for publication. Ability to manage multiple tasks with competing timelines. Excellent communication and collaboration skills. Ability to explain statistical concepts to non-statisticians. Solution oriented, attention to detail, interest and ability to perform in a high-demand and dynamic working environment. Able to travel as needed (10%-15%). Total Rewards Offerings: Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization. Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off. Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees. Target Base Pay Range: $150,000.00 - $195,000.00 *This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location. Travere will accept applications on an ongoing basis until a candidate is selected for the position. If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
