Associate Director - Data Standards (Hybrid)
AbbVie
June 24, 2026
Remote friendly (Irvine, 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 in-depth understanding of CDISC guidance/implementation guides and FDA guidance/regulations for electronic submission; stay current on trends in data mapping, data management, standards compliance, metadata management, and data warehousing.
- Review eCRF designs for CDASH/SDTM conformance; proactively identify and correct issues.
- Review SDTM conformance mapping specifications; provide CDISC expertise for cross-functional source-to-SDTM mapping.
- Interpret and execute CDISC validation tools (SDTM/define.xml, ADaM/define.xml); collaborate to resolve issues and document unresolved items.
- Manage CDISC metadata/terminology within the metadata repository; provide governance oversight to ensure metadata consistency.
- Assist in development of data standards policies, procedures and practices.
- Communicate data standards/regulatory concepts to cross-functional teams; represent Data Standards group interests.
- Ensure training compliance; mentor and train Data Standards team.
- Support CDISC public review and submit at least one abstract per year to CDISC Interchange.
Qualifications (Minimum):
- B.S.; 12+ years clinical research experience (or 10+ with Masters).
- Expert in at least 3: CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management; high level in one additional area.
- Familiarity with BRIDG, ODM, SHARE.
- Experience mapping/converting legacy data to SDTM for eCTD; minimum two successful CDISC-compliant submissions.
- Knowledge of international clinical data standards regulations/guidance and regulatory dataset preparation.
- Metadata repository technology and governance experience; metadata management to support systems/processes.
Responsibilities:
- Ensure compliance with applicable Corporate and Divisional policies and procedures.
- Maintain in-depth understanding of CDISC guidance/implementation guides and FDA guidance/regulations for electronic submission; stay current on trends in data mapping, data management, standards compliance, metadata management, and data warehousing.
- Review eCRF designs for CDASH/SDTM conformance; proactively identify and correct issues.
- Review SDTM conformance mapping specifications; provide CDISC expertise for cross-functional source-to-SDTM mapping.
- Interpret and execute CDISC validation tools (SDTM/define.xml, ADaM/define.xml); collaborate to resolve issues and document unresolved items.
- Manage CDISC metadata/terminology within the metadata repository; provide governance oversight to ensure metadata consistency.
- Assist in development of data standards policies, procedures and practices.
- Communicate data standards/regulatory concepts to cross-functional teams; represent Data Standards group interests.
- Ensure training compliance; mentor and train Data Standards team.
- Support CDISC public review and submit at least one abstract per year to CDISC Interchange.
Qualifications (Minimum):
- B.S.; 12+ years clinical research experience (or 10+ with Masters).
- Expert in at least 3: CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management; high level in one additional area.
- Familiarity with BRIDG, ODM, SHARE.
- Experience mapping/converting legacy data to SDTM for eCTD; minimum two successful CDISC-compliant submissions.
- Knowledge of international clinical data standards regulations/guidance and regulatory dataset preparation.
- Metadata repository technology and governance experience; metadata management to support systems/processes.