Strategic Lead, Statistical Programming

travere; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director of Statistical Programming to provide hands-on programming support across programs. The role leads external vendors, ensures timely deliverables, and drives standards for SDTM/ADaM and Define.xml in a cross-functional Biometric team.

The candidate will oversee programming activities, develop SAPs and data specifications, and contribute to regulatory submissions with strong SAS and UNIX/Windows expertise.

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics or related technical discipline; Masters preferred.
• Minimum 8 years' experience in clinical research with SAS programming in pharma/CRO settings.
• 3-5 years of progressive leadership experience with at least 3 years as Lead Programmer.

Responsibilities

• Provide strategic input for programming processes and maintain SOPs and standards.
• Lead projects, oversee contractors, and ensure timely quality programming deliverables.
• Program data sets, tables, figures, listings and submission components (ISS/ISE/DSUR/PSUR/Define.xml).
• Develop/review SAPs, CRFs, DB specifications, validation plans, and TLFs.

Skills

SAS programming

SDTM

ADaM

CDISC standards

Regulatory submissions

Unix

Windows

MS Office

R (plus)

Cross-functional collaboration

Education

Bachelor's degree in Statistics

Bachelor's degree in Computer Science

Bachelor's degree in Mathematics

Master's degree preferred

Tools

SAS

UNIX

Windows

R

MS Office

Define.XML

Job description

Travere Therapeutics is seeking an Associate Director of Statistical Programming to provide hands-on programming support across programs. The role leads external vendors, ensures timely deliverables, and drives standards for SDTM/ADaM and Define.xml in a cross-functional Biometric team.

The candidate will oversee programming activities, develop SAPs and data specifications, and contribute to regulatory submissions with strong SAS and UNIX/Windows expertise.