Executive Director, Statistical Programming

Responsibilities

• Serve as head of the Statistical Programming function within the Biometrics Department.
• Provide strategic input and leadership to the delivery of statistical programming contributions across all clinical development projects.
• Overall accountability of programming deliverables required to support the analysis and reporting for clinical development projects.
• Lead and contribute to the development and review of case report forms, clinical DB 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 that 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 (i.e., contractors or CROs). Conduct vendor qualifications and GCP audits (in collaboration with QA), as appropriate.
• 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).
• Education/Experience Requirements:
• Bachelor's degree in Statistics, Computer Science, Mathematics, or a related technical discipline required. Masters 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.
• 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.
• Strong managerial / technical understanding of programming and clinical related issues along with an ability to demonstrate significant leadership of

Benefits

Additional Information

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 Executive Director, Statistical Programming will lead the Statistical Programming function within the Biometrics Department and will work closely with the head of Biometrics in identifying project programming demands and resource needs. The ideal candidate will provide hands-on support to project teams by carrying out and conducting 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 will contribute to the overall efficiency and best practice running 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.

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