Associate Director, Statistical Programming — Remote

Travere Therapeutics; Kansas City (MO); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Well-being programs

Paid time off

Job summary

Travere Therapeutics seeks an Associate Director, Statistical Programming in San Diego to provide hands-on programming and validation across all programs, lead projects, and oversee external vendors. The role requires expertise in SDTM/ADaM, Define.xml, and regulatory submissions, with strong cross-functional collaboration.

The ideal candidate will have 8+ years in clinical research, SAS programming, and 3+ years of leadership experience, plus a proven track record in developing programming

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics, or a related technical discipline. Masters preferred.
• 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.

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.

Job description

Travere Therapeutics seeks an Associate Director, Statistical Programming in San Diego to provide hands-on programming and validation across all programs, lead projects, and oversee external vendors. The role requires expertise in SDTM/ADaM, Define.xml, and regulatory submissions, with strong cross-functional collaboration.

The ideal candidate will have 8+ years in clinical research, SAS programming, and 3+ years of leadership experience, plus a proven track record in developing programming