Associate Director, Statistical Programming
Corcept Therapeutics
August 15, 2026
On-site
Redwood City, CA
Clinical Research and Development
Responsibilities:
- Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications.
- Review the Statistical Analysis Plan; develop specifications; write and execute SAS programs for study data analysis and clinical study report preparation.
- Develop specifications; build and execute SAS programs for internal data reviews, publications, exploratory, post-hoc, and regulatory review.
- Develop SAS macros and tools for repeated program use for exploratory and post-hoc analyses.
- Manage on-time and quality delivery of CRO-generated analyses results.
- Review and provide feedback on CRO Statistical Analysis Plans and SDTM/ADaM specifications for domain/analysis dataset development, CDISC compliance, and output displays.
- Validate data and results from CRO-generated statistical analyses.
- Manage internal programming resources for study deliverables as applicable.
- Stay current with regulatory requirements for CDISC and clinical regulatory programming standards.
- Use CDISC implementation guides and validation software to check compliance of CDISC packages (SEND, SDTM, ADaM, define.xmls, reviewer’s guides).
- Evaluate CDISC electronic data packages for completeness, compliance, and submission readiness.
- Participate in standards governance and develop biometric department operational processes as applicable.
- Establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs/datasets.
Preferred Skills/Qualifications/Technical Proficiencies:
- In-depth knowledge of SAS Base, Macro, STAT, GRAPH, ACCESS.
- In-depth knowledge of CDISC SDTM/ADaM specifications and related regulatory guidance.
- In-depth knowledge of Pinnacle 21 for addressing errors/warnings to generate acceptable reviewer’s guides (SDRG/ADRG).
- Knowledge of clinical trial design, data collection, endpoints, statistical methods, and standard displays (oncology/endocrine preferred).
- Familiarity with Spotfire, Tableau, or RShiny (plus).
- Ability to operate independently in unstructured situations.
- Ability to communicate technical information to non-technical audiences.
Preferred Education/Experience:
- Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering, or related field (MS preferred).
- 10+ years of clinical trial development experience (late stage preferred).
- FDA/EMEA submission experience (plus).
- Demonstrated project management of statistical programming projects; CRO delivery management experience.
- Creative problem-solving; hands-on approach.
Application instructions:
- Applicants must be authorized to work in the United States on a full-time basis.
- Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications.
- Review the Statistical Analysis Plan; develop specifications; write and execute SAS programs for study data analysis and clinical study report preparation.
- Develop specifications; build and execute SAS programs for internal data reviews, publications, exploratory, post-hoc, and regulatory review.
- Develop SAS macros and tools for repeated program use for exploratory and post-hoc analyses.
- Manage on-time and quality delivery of CRO-generated analyses results.
- Review and provide feedback on CRO Statistical Analysis Plans and SDTM/ADaM specifications for domain/analysis dataset development, CDISC compliance, and output displays.
- Validate data and results from CRO-generated statistical analyses.
- Manage internal programming resources for study deliverables as applicable.
- Stay current with regulatory requirements for CDISC and clinical regulatory programming standards.
- Use CDISC implementation guides and validation software to check compliance of CDISC packages (SEND, SDTM, ADaM, define.xmls, reviewer’s guides).
- Evaluate CDISC electronic data packages for completeness, compliance, and submission readiness.
- Participate in standards governance and develop biometric department operational processes as applicable.
- Establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs/datasets.
Preferred Skills/Qualifications/Technical Proficiencies:
- In-depth knowledge of SAS Base, Macro, STAT, GRAPH, ACCESS.
- In-depth knowledge of CDISC SDTM/ADaM specifications and related regulatory guidance.
- In-depth knowledge of Pinnacle 21 for addressing errors/warnings to generate acceptable reviewer’s guides (SDRG/ADRG).
- Knowledge of clinical trial design, data collection, endpoints, statistical methods, and standard displays (oncology/endocrine preferred).
- Familiarity with Spotfire, Tableau, or RShiny (plus).
- Ability to operate independently in unstructured situations.
- Ability to communicate technical information to non-technical audiences.
Preferred Education/Experience:
- Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering, or related field (MS preferred).
- 10+ years of clinical trial development experience (late stage preferred).
- FDA/EMEA submission experience (plus).
- Demonstrated project management of statistical programming projects; CRO delivery management experience.
- Creative problem-solving; hands-on approach.
Application instructions:
- Applicants must be authorized to work in the United States on a full-time basis.