Manager, Clinical Data and Reporting Standards - SDTM Programming (Hybrid)
AbbVie
August 26, 2026
Remote friendly (South San Francisco, CA)
United States
$109,500 - $208,500 USD yearly
Clinical Research and Development
The Manager, Clinical Data and Reporting Standards (CDARS) proactively supports the development of data and reporting standards for AbbVie’s clinical trials, ensuring conformance to CDISC standards and industry best practices, including pipeline-based SDTM development. Implements the governance strategy/framework for standards and engages in deployment of next-generation process and technology.
Responsibilities
- Participate with cross-functional SMEs to define standards for assigned therapeutic areas: Data Collection, Data Review Rules, SDTM mapping; ADaM mapping/derivation; study-level tables/listings/figures; product-level safety analysis displays.
- Ensure standards are clearly defined with documented assumptions/decisions.
- Ensure consistency across standard types (e.g., eCRF/TLF, SDTM/ADaM).
- Develop training materials and communicate standard development activities organization-wide.
- Provide feedback on CRF design and SDTM datasets for regulatory compliance (CDASH, SDTM, ADaM and AbbVie extensions).
- Review and provide feedback on SDTM Trial Design Domains.
- Support SDTM programming based on SDTM specifications.
- Oversee creation of SDTM datasets, define.xml, annotated CRFs, and Clinical Study Data Reviewer’s Guides for FDA and PMDA submissions.
- Consult on SDTM/ADaM conformance issues and resolve via data/metadata correction or appropriate explanations.
- Represent AbbVie’s interests in industry standards development; stay current with CDISC and regulatory requirements; identify and drive improvements to standards.
Qualifications
- Minimum: MS with 8 years relevant clinical research experience, or BS with 10 years; SDTM experience required; experience leading standards development for data collection/tabulation/analysis/reporting; experience preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.
- Preferred: CDASH experience highly recommended; ADaM/Analysis Results Metadata/TLF experience helpful; active participation in CDISC teams preferred.
Responsibilities
- Participate with cross-functional SMEs to define standards for assigned therapeutic areas: Data Collection, Data Review Rules, SDTM mapping; ADaM mapping/derivation; study-level tables/listings/figures; product-level safety analysis displays.
- Ensure standards are clearly defined with documented assumptions/decisions.
- Ensure consistency across standard types (e.g., eCRF/TLF, SDTM/ADaM).
- Develop training materials and communicate standard development activities organization-wide.
- Provide feedback on CRF design and SDTM datasets for regulatory compliance (CDASH, SDTM, ADaM and AbbVie extensions).
- Review and provide feedback on SDTM Trial Design Domains.
- Support SDTM programming based on SDTM specifications.
- Oversee creation of SDTM datasets, define.xml, annotated CRFs, and Clinical Study Data Reviewer’s Guides for FDA and PMDA submissions.
- Consult on SDTM/ADaM conformance issues and resolve via data/metadata correction or appropriate explanations.
- Represent AbbVie’s interests in industry standards development; stay current with CDISC and regulatory requirements; identify and drive improvements to standards.
Qualifications
- Minimum: MS with 8 years relevant clinical research experience, or BS with 10 years; SDTM experience required; experience leading standards development for data collection/tabulation/analysis/reporting; experience preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.
- Preferred: CDASH experience highly recommended; ADaM/Analysis Results Metadata/TLF experience helpful; active participation in CDISC teams preferred.