Senior Statistical Programming Lead (Remote)

Travere Therapeutics

Columbus (OH)

On-site

USD 150,000 - 195,000

Full time

14 days+

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Job summary

Travere Therapeutics in San Diego is seeking an Associate Director of Statistical Programming to provide hands-on programming, validation, and vendor oversight across all programs in the Biometrics team.

The ideal candidate will lead projects, develop standards, and ensure timely, high-quality submissions while supporting cross-functional collaboration and development programming best practices.

Qualifications

  • Bachelor's degree in Statistics, CS or Mathematics (Masters preferred).
  • 8+ years' experience in clinical research SAS programming.
  • 3-5 years of progressive leadership as Lead Programmer.
  • Experience supervising vendors and cross-functional teams.
  • Strong knowledge of CDISC standards (SDTM/ADaM/Define.XML) and regulatory submissions.
  • Proficiency with SAS (ODS, SQL, MACRO, GRAPH, ACCESS); familiarity with R is a plus.
  • Experience with UNIX and Windows operating systems.
  • Excellent communication and project-management skills.

Responsibilities

  • Provides strategic input regarding the development of 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 efficiency for analysis and reporting in clinical development.
  • Lead projects/studies, oversee contractors, and ensure quality and timeliness of programming deliverables.
  • Program analysis datasets, tables, figures, listings, ISS/ISE, DSUR, PSUR, IB, progress reports, and regulatory submissions.
  • Reviews/Develops CDISC specifications and define.xml documentation for submissions.
  • Provides programming support for clinical study reports, oversees CROs, and coordinates with Biometrics lead and data managers.
  • Develops/reviews SAPs, CRFs, validation plans, TLFs, and datasets specifications.
  • Applies programming methodologies to support the clinical development process.

Skills

SAS programming
CDISC SDTM/ADaM/Define.XML
UNIX
Windows
R (plus)
Vendor management
Leadership
Regulatory submissions
SAS macros/ODS/SQL

Education

Bachelor's in Statistics/CS/Math
Master's preferred

Tools

UNIX
Windows

Job description

Travere Therapeutics in San Diego is seeking an Associate Director of Statistical Programming to provide hands-on programming, validation, and vendor oversight across all programs in the Biometrics team.

The ideal candidate will lead projects, develop standards, and ensure timely, high-quality submissions while supporting cross-functional collaboration and development programming best practices.

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