Associate Director, Statistical Programming

Associate Director, Statistical Programming

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, Statistical Programming works closely with the Executive Director, Statistical Programming and other members of the Biometrics team to provide programming support across all programs. The ideal candidate will provide hands-on programming and validation support to project teams and oversee external vendors to ensure timely and accurate deliverables. This role will also provide technical expertise to development programming standards and procedures and will work cross-functionally.

Strong technical skills and experiences supporting submissions are required.

Responsibilities:

• Provides strategic input regarding the development of statistical programming processes and contribute to maintaining programming-related SOPs, work instructions, and technical standards.
• Assists in the development of programming standards and tools to improve the efficiency and accuracy required to support the analysis and reporting for clinical development projects.
• Lead projects/studies, oversee contractors, and ensure quality and timeliness of programming deliverables.
• Program 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).
• Reviews/Develops CDISC specifications and review/generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation for submissions.
• Provides statistical programming and validation support for clinical study reports, oversee external vendors (e.g., CROs), and coordinate programming activities with Biometrics lead, data managers, and other study programmers.
• Develops and/or reviews SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.
• Provides input on the application of programming methodologies to support the clinical development process.

Education/Experience Requirements:

• Bachelor's degree in Statistics, Computer Science, Mathematics, or a related technical discipline. Masters preferred. Equivalent combination of education and applicable job experience may be considered.
• Minimum 8 years' experience in clinical research, ideally as a SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
• 3-5 years of progressive leadership experience with at least 3 years' experience as Lead Programmer is required.

Additional Skills/

Experience:

• The ideal candidate will embody Travere's core values:
  Courage, Community Spirit, Patient Focus and Teamwork.
• Experience in managing vendors and/or direct reports.
• Technical knowledge and experience with SDTM, ADaM, and Define.
  
  XML.
• Strong understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
• Submission support with compliance experience.
• Thorou…