Associate Director - Data Standards (Hybrid)
AbbVie
June 24, 2026
Remote friendly (North Chicago, IL)
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 in-depth knowledge of CDISC guidance/implementation guides and FDA guidance/regulations for electronic data submission; stay current on data mapping, data management, standards compliance, metadata management, and data warehousing
- Review eCRF designs for compatibility/conformance with CDASH/SDTM; proactively correct flaws
- Review SDTM conformance mapping specifications; provide CDISC expertise for cross-functional source-to-SDTM mapping
- Execute and interpret CDISC validation tools (define.xml for SDTM/ADaM); document unresolved issues (e.g., FDA Data Reviewers Guides); resolve validation issues with other functions
- Manage CDISC metadata/terminology/standards in a metadata repository; provide governance oversight
- Assist with development of data standards policies/procedures
- Communicate clinical data standards and regulatory guidance; represent Data Standards group in cross-functional initiatives
- Mentor/train data standards peers and new analysts
- Provide CDISC external expertise; coordinate consolidated review comments for public releases; submit at least one abstract/year for CDISC Interchange
Qualifications:
- B.S.; 12+ years relevant clinical research experience (or 10+ with a Masters)
- Expert in at least 3 areas: CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management; high knowledge in at least one additional area
- Familiarity with BRIDG, ODM, SHARE
- Experience converting legacy data to SDTM domains for eCTD; minimum two successful CDISC-compliant submissions
- Knowledge of international regulations/guidance for clinical data standards and regulatory dataset preparation
- Experience with metadata repository technology and governance
Benefits (if eligible): 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 in-depth knowledge of CDISC guidance/implementation guides and FDA guidance/regulations for electronic data submission; stay current on data mapping, data management, standards compliance, metadata management, and data warehousing
- Review eCRF designs for compatibility/conformance with CDASH/SDTM; proactively correct flaws
- Review SDTM conformance mapping specifications; provide CDISC expertise for cross-functional source-to-SDTM mapping
- Execute and interpret CDISC validation tools (define.xml for SDTM/ADaM); document unresolved issues (e.g., FDA Data Reviewers Guides); resolve validation issues with other functions
- Manage CDISC metadata/terminology/standards in a metadata repository; provide governance oversight
- Assist with development of data standards policies/procedures
- Communicate clinical data standards and regulatory guidance; represent Data Standards group in cross-functional initiatives
- Mentor/train data standards peers and new analysts
- Provide CDISC external expertise; coordinate consolidated review comments for public releases; submit at least one abstract/year for CDISC Interchange
Qualifications:
- B.S.; 12+ years relevant clinical research experience (or 10+ with a Masters)
- Expert in at least 3 areas: CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management; high knowledge in at least one additional area
- Familiarity with BRIDG, ODM, SHARE
- Experience converting legacy data to SDTM domains for eCTD; minimum two successful CDISC-compliant submissions
- Knowledge of international regulations/guidance for clinical data standards and regulatory dataset preparation
- Experience with metadata repository technology and governance
Benefits (if eligible): paid time off, medical/dental/vision insurance, 401(k); eligible for long-term incentive programs