Executive Director, Statistical Programming
Travere Therapeutics
August 30, 2026
On-site
United States
Clinical Research and Development
Position Summary:
- Lead the Statistical Programming function within the Biometrics Department and coordinate project programming demands, resourcing, programming and validation activities for clinical studies.
Responsibilities:
- Head Statistical Programming; provide strategic leadership across all clinical development projects.
- Own programming deliverables for analysis and reporting (datasets, TFLs, tables/figures/listings, ISS/ISE, DSUR/PSUR, IB, progress reports, electronic submissions, and responses to regulatory/publication requests).
- Lead/review CRFs, clinical DB specs, SAP, reporting & analysis dataset specs, validation plans, and TLFs.
- Ensure quality; develop/maintain programming SOPs, standards, and specifications.
- Ensure systems/processes are scalable, connected, and secure (with IT/QA).
- Manage oversight of CROs/contractors; support vendor qualifications and GCP audits (with QA).
- Apply programming methodologies across clinical development; develop/maintain applications for analysis/reporting.
- Manage and develop programmers; conduct trainings/coaching; represent Biometrics in cross-functional initiatives.
Education/Experience:
- BS in Statistics/CS/Math (or related); MS preferred. 14+ years clinical SAS programming (Phase I–IV) in pharma/CRO; 7+ years in leadership/management.
Skills/Experience:
- SAS (ODS, SQL, MACRO, STAT, GRAPH, ACCESS), MS Office; R a plus; UNIX/Windows.
- SDTM, ADaM, Define.XML; strong submission/regulatory knowledge (CDISC/CDASH/eCTD; ICH/CHMP/FDA/GCP); submission compliance experience.
- Travel ~10%; role is not 100% remote.
Benefits:
- Premium health/financial/work-life/well-being, wellness support, life insurance, disability, retirement match, generous paid time off.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.
- Lead the Statistical Programming function within the Biometrics Department and coordinate project programming demands, resourcing, programming and validation activities for clinical studies.
Responsibilities:
- Head Statistical Programming; provide strategic leadership across all clinical development projects.
- Own programming deliverables for analysis and reporting (datasets, TFLs, tables/figures/listings, ISS/ISE, DSUR/PSUR, IB, progress reports, electronic submissions, and responses to regulatory/publication requests).
- Lead/review CRFs, clinical DB specs, SAP, reporting & analysis dataset specs, validation plans, and TLFs.
- Ensure quality; develop/maintain programming SOPs, standards, and specifications.
- Ensure systems/processes are scalable, connected, and secure (with IT/QA).
- Manage oversight of CROs/contractors; support vendor qualifications and GCP audits (with QA).
- Apply programming methodologies across clinical development; develop/maintain applications for analysis/reporting.
- Manage and develop programmers; conduct trainings/coaching; represent Biometrics in cross-functional initiatives.
Education/Experience:
- BS in Statistics/CS/Math (or related); MS preferred. 14+ years clinical SAS programming (Phase I–IV) in pharma/CRO; 7+ years in leadership/management.
Skills/Experience:
- SAS (ODS, SQL, MACRO, STAT, GRAPH, ACCESS), MS Office; R a plus; UNIX/Windows.
- SDTM, ADaM, Define.XML; strong submission/regulatory knowledge (CDISC/CDASH/eCTD; ICH/CHMP/FDA/GCP); submission compliance experience.
- Travel ~10%; role is not 100% remote.
Benefits:
- Premium health/financial/work-life/well-being, wellness support, life insurance, disability, retirement match, generous paid time off.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.