Executive Director, Statistical Programming
Travere Therapeutics
August 08, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Clinical Research and Development
Position Summary:
The Executive Director, Statistical Programming will lead the Statistical Programming function within the Biometrics Department, providing hands-on statistical programming and validation support for clinical studies. Work closely with Biometrics leadership, vendors, statisticians, and other functions to ensure timely and accurate programming deliverables and submissions.
Responsibilities:
- Head the Statistical Programming function; provide strategic leadership across clinical development projects.
- Own programming deliverables supporting analysis and reporting for clinical development projects.
- Provide programming and validation support for clinical study reports; coordinate programming for analysis datasets, tables/figures/listings, ISS/ISE, DSUR, PSUR, IB, progress reports, electronic submissions, and regulatory/publication responses.
- Lead/review case report forms, clinical DB specifications, SAP, dataset specifications, validation plans, and TLFs.
- Ensure quality of all programming deliverables; develop/maintain programming SOPs, standards, and specification documents.
- Ensure Biometrics systems/processes meet scalability, connectivity, and security needs (with IT/QA).
- Manage/oversee contractors/CROs; conduct vendor qualifications and GCP audits as appropriate.
- Apply programming methodologies; develop/maintain analysis/reporting applications.
- Manage programmers; train and coach staff.
- May represent Biometrics in cross-departmental process/quality initiatives.
Education/Experience:
- Bachelor’s degree (Statistics/CS/Math or related); Master’s preferred.
- 14+ years clinical SAS programming (Phase I–IV) in pharma/CRO; 7+ years leadership/management.
Skills/Requirements:
- Leadership in clinical SAS programming; extensive vendor/direct report management.
- SDTM, ADaM, Define.XML; drug development and submission/regulatory requirements (CDISC/CDASH/eCTD; ICH/CHMP/FDA/GCP).
- SAS (ODS, SQL, MACRO, STAT, GRAPH, ACCESS); MS Office; R is a plus.
- UNIX/Windows; strong SDLC knowledge; ability to communicate in dynamic environment; travel ~10%.
- Onsite/face-to-face in San Diego required; not fully remote.
Benefits:
- Premium health, financial/work-life well-being, wellness support, life insurance, disability, retirement with employer match, and generous paid time off.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.
The Executive Director, Statistical Programming will lead the Statistical Programming function within the Biometrics Department, providing hands-on statistical programming and validation support for clinical studies. Work closely with Biometrics leadership, vendors, statisticians, and other functions to ensure timely and accurate programming deliverables and submissions.
Responsibilities:
- Head the Statistical Programming function; provide strategic leadership across clinical development projects.
- Own programming deliverables supporting analysis and reporting for clinical development projects.
- Provide programming and validation support for clinical study reports; coordinate programming for analysis datasets, tables/figures/listings, ISS/ISE, DSUR, PSUR, IB, progress reports, electronic submissions, and regulatory/publication responses.
- Lead/review case report forms, clinical DB specifications, SAP, dataset specifications, validation plans, and TLFs.
- Ensure quality of all programming deliverables; develop/maintain programming SOPs, standards, and specification documents.
- Ensure Biometrics systems/processes meet scalability, connectivity, and security needs (with IT/QA).
- Manage/oversee contractors/CROs; conduct vendor qualifications and GCP audits as appropriate.
- Apply programming methodologies; develop/maintain analysis/reporting applications.
- Manage programmers; train and coach staff.
- May represent Biometrics in cross-departmental process/quality initiatives.
Education/Experience:
- Bachelor’s degree (Statistics/CS/Math or related); Master’s preferred.
- 14+ years clinical SAS programming (Phase I–IV) in pharma/CRO; 7+ years leadership/management.
Skills/Requirements:
- Leadership in clinical SAS programming; extensive vendor/direct report management.
- SDTM, ADaM, Define.XML; drug development and submission/regulatory requirements (CDISC/CDASH/eCTD; ICH/CHMP/FDA/GCP).
- SAS (ODS, SQL, MACRO, STAT, GRAPH, ACCESS); MS Office; R is a plus.
- UNIX/Windows; strong SDLC knowledge; ability to communicate in dynamic environment; travel ~10%.
- Onsite/face-to-face in San Diego required; not fully remote.
Benefits:
- Premium health, financial/work-life well-being, wellness support, life insurance, disability, retirement with employer match, and generous paid time off.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.