Executive Director, Statistical Programming

Be part of a global team 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 and seek talented individuals who will thrive in our collaborative, diverse, and fast-paced environment while sharing our mission to identify, develop, and deliver life-changing therapies.

About the role

The Executive Director, Statistical Programming will lead the Statistical Programming function within the Biometrics Department and work closely with the head of Biometrics to identify project programming demands and resource needs. The ideal candidate will provide hands-on support to project teams by carrying out programming activities, leading statistical programmers, and coordinating with external vendors, statisticians, and other business functions to ensure timely and accurate programming and validation activities for clinical studies. This role contributes to the overall efficiency and best practices of the Biometrics Department, demonstrating the ability to work efficiently and to a high standard within a cross-functional team environment. Strong technical skills and experience supporting submissions are required.

Responsibilities

• Serve as head of the Statistical Programming function within the Biometrics Department.
• Provide strategic input and leadership for statistical programming contributions across all clinical development projects.
• Hold overall accountability for programming deliverables required to support analysis and reporting for clinical development projects.
• Provide statistical programming and validation support for clinical study reports and coordinate programming activities among study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions, and other internal and external requests (e.g., publications, responses to regulatory questions).
• Lead and contribute to the development and review of case report forms, clinical database specifications, SAP, reporting and analysis datasets specifications, validation plans, and TLFs.
• Ensure quality of all project programming deliverables.
• Lead the development and maintenance of programming-related SOPs, work practice documents, technical standards, and programming specification documents.
• Ensure Biometrics systems and processes are up to date in terms of scalability, connectivity, and security, in collaboration with IT and QA.
• Manage or provide oversight to third-party service providers (e.g., contractors or CROs). Conduct vendor qualifications and GCP audits (in collaboration with QA), as appropriate.
• Identify and lead the application of programming methodologies to support all aspects of the clinical development process. Leverage programming tools to convert data into information enabling decision-making.
• Identify the need for and lead the development and maintenance of applications used for analysis and reporting.
• Manage programmers and contribute to the professional development of Biometrics personnel by conducting trainings and coaching.
• May represent the Biometrics Department in cross-departmental initiatives and projects (e.g., process and quality improvements).

Requirements

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline required; Master’s preferred. Equivalent combination of education and applicable job experience may be considered.
• 14+ years of experience in clinical SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment, with at least 7 years in a leadership or management role.
• Strong managerial and technical understanding of programming and clinical-related issues, with demonstrated leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment.
• Extensive experience managing vendors and direct reports.
• Extensive technical knowledge and experience with SDTM, ADaM, and Define.XML.
• Strong understanding of the drug development process, submission-related activities, and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP).
• Submission support with compliance experience.
• Advanced knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office; familiarity or experience with R Software is a plus.
• Proven experience with UNIX or Windows operating systems.
• Strong understanding of the software development and maintenance life cycle.
• Ability to effectively communicate and perform in a high-demand and dynamic working environment.
• Ability to travel 10% domestically and internationally.
• All positions require the ability to perform face-to-face work with colleagues and/or onsite in San Diego; no role is expected to be 100% remote.

Benefits

Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization. Benefits include:

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with employer match.
• Generous paid time off.

Pay

Our competitive compensation package includes a combination of 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: $246,000.00 - $332,000.00. Actual pay offered to a candidate will depend on factors including experience, education, skills, and location.