Associate Director - Data Standards (Hybrid)
AbbVie
August 07, 2026
Remote friendly (South San Francisco, CA)
United States
$141,500 - $268,500 USD yearly
IT
Lead, manage and develop a group of data standards experts to develop, implement and maintain end-to-end data standards from data collection to regulatory submission. Govern change control, publication and communication of new and updated data standards.
Responsibilities:
- Ensure compliance with applicable Corporate and Divisional policies and procedures
- Maintain deep knowledge of CDISC guidance/implementation guides and FDA guidance/regulations for electronic submission; track trends in data mapping, data management, standards compliance, metadata management and data warehousing
- Review eCRF designs for CDASH/SDTM compatibility/conformance; proactively identify and correct issues
- Review SDTM conformance mapping specifications; proactively correct flaws; provide CDISC expertise for source-to-SDTM mapping
- Execute and interpret SDTM/ADaM validation tools (define.xml); resolve issues with other functions; document unresolved issues
- Manage CDISC-related metadata/terminology/standards in the metadata repository; provide governance oversight
- Assist with development of data standards policies/procedures/practices
- Communicate data standards concepts and regulatory guidance; represent Data Standards group interests in cross-functional initiatives
- Mentor and train team members; ensure training compliance
- Support CDISC standards public review comment consolidation and submit at least one abstract per year to a CDISC Interchange
Minimum Qualifications:
- B.S.; 12+ years clinical research (or 10+ with a Masters)
- Expert knowledge in at least 3 clinical data standards areas; high knowledge in at least one additional area (e.g., CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management)
- Familiarity with BRIDG, ODM, SHARE
- Experience mapping legacy data to SDTM domains for eCTD; minimum two successful CDISC-compliant submissions
- Knowledge of international regulations for clinical data standards and regulatory dataset preparation
- Experience with metadata repository technology and data standards governance
Benefits (as stated): paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.
Responsibilities:
- Ensure compliance with applicable Corporate and Divisional policies and procedures
- Maintain deep knowledge of CDISC guidance/implementation guides and FDA guidance/regulations for electronic submission; track trends in data mapping, data management, standards compliance, metadata management and data warehousing
- Review eCRF designs for CDASH/SDTM compatibility/conformance; proactively identify and correct issues
- Review SDTM conformance mapping specifications; proactively correct flaws; provide CDISC expertise for source-to-SDTM mapping
- Execute and interpret SDTM/ADaM validation tools (define.xml); resolve issues with other functions; document unresolved issues
- Manage CDISC-related metadata/terminology/standards in the metadata repository; provide governance oversight
- Assist with development of data standards policies/procedures/practices
- Communicate data standards concepts and regulatory guidance; represent Data Standards group interests in cross-functional initiatives
- Mentor and train team members; ensure training compliance
- Support CDISC standards public review comment consolidation and submit at least one abstract per year to a CDISC Interchange
Minimum Qualifications:
- B.S.; 12+ years clinical research (or 10+ with a Masters)
- Expert knowledge in at least 3 clinical data standards areas; high knowledge in at least one additional area (e.g., CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management)
- Familiarity with BRIDG, ODM, SHARE
- Experience mapping legacy data to SDTM domains for eCTD; minimum two successful CDISC-compliant submissions
- Knowledge of international regulations for clinical data standards and regulatory dataset preparation
- Experience with metadata repository technology and data standards governance
Benefits (as stated): paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.