Associate Director, Statistical Programming (Remote)

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

Job summary

Travere Therapeutics in San Diego (onsite) seeks an Associate Director, Statistical Programming to lead programming across programs, mentor staff, and coordinate with CROs. Strong SAS and CDISC expertise required.

You will develop SDTM/ADaM datasets, Define.xml, SAPs, and support regulatory submissions while managing timelines and budgets in a fast-paced biometrics team. This role demands leadership, collaboration, and a deep understanding of clinical trial processes and regulatory guidelines.

Qualifications

• 8+ years in clinical research with SAS programming in pharma/CRO environment.
• 3-5 years progressive leadership with at least 3 years as Lead Programmer.
• Experience with SDTM, ADaM, Define.XML and regulatory submission support.

Responsibilities

• Provides strategic input on programming processes and maintains SOPs and standards.
• Develops programming standards/tools to improve efficiency for clinical development projects.
• Lead projects, oversee contractors, and ensure quality/timeliness of deliverables.
• Program analysis datasets, tables, figures, listings, and regulatory deliverables (ISS/ISE, DSUR, PSUR, IB).
• Reviews/Develops CDISC specs and Define.xml with supporting documentation for submissions.
• Provides programming support for study reports and coordinates activities with Biometrics lead and data managers.

Education

Bachelor's degree in Statistics, Computer Science, Mathematics, or related technical discipline

Master's degree preferred

Tools

SAS

CDISC

SDTM

ADaM

Define.XML

R

UNIX

Windows

MS Office

Job description

Travere Therapeutics in San Diego (onsite) seeks an Associate Director, Statistical Programming to lead programming across programs, mentor staff, and coordinate with CROs. Strong SAS and CDISC expertise required.

You will develop SDTM/ADaM datasets, Define.xml, SAPs, and support regulatory submissions while managing timelines and budgets in a fast-paced biometrics team. This role demands leadership, collaboration, and a deep understanding of clinical trial processes and regulatory guidelines.