Associate Director - Data Standards (Hybrid)
AbbVie
August 06, 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 deep understanding of CDISC guidance/implementation guides and FDA guidance/regulations for electronic data submission; track trends in data mapping, data management, standards compliance, metadata management and data warehousing.
- eCRF Design: review eCRF designs for conformance with CDASH/SDTM; proactively correct flaws.
- SDTM Conformance Mapping: review/correct SDTM conformance mapping specifications; provide CDISC expertise for cross-functional source-to-SDTM mapping.
- CDISC Validation Tools: interpret results from validation tools; execute validation and collaborate to resolve issues; document unresolved issues (e.g., FDA Data Reviewers Guides).
- Metadata Repository: manage CDISC metadata/terminology libraries; provide governance oversight to ensure metadata consistency.
- Assist in developing data standards policies, procedures and practices.
- Communicate standards concepts and regulatory guidance; represent the Data Standards group in cross-functional initiatives.
- Training & Mentoring: meet training requirements; mentor and train data standards personnel.
- CDISC involvement: manage review comments for public standards; submit at least one abstract per year for CDISC interchange.
Minimum Qualifications:
- B.S.; 12+ years clinical research experience (or 10+ with a Masters).
- Expert knowledge in at least 3 clinical data standards areas (e.g., CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management) and high knowledge in at least one additional area.
- Familiarity with BRIDG, ODM, SHARE.
- Experience mapping/converting legacy data into SDTM domains for eCTD submissions; at least two successful CDISC-compliant submissions.
- Knowledge of international regulations for clinical data standards and regulatory submission datasets.
- Experience with metadata repository technology and data standards governance.
Benefits (if part of job description): paid time off (vacation/holidays/sick), 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 understanding of CDISC guidance/implementation guides and FDA guidance/regulations for electronic data submission; track trends in data mapping, data management, standards compliance, metadata management and data warehousing.
- eCRF Design: review eCRF designs for conformance with CDASH/SDTM; proactively correct flaws.
- SDTM Conformance Mapping: review/correct SDTM conformance mapping specifications; provide CDISC expertise for cross-functional source-to-SDTM mapping.
- CDISC Validation Tools: interpret results from validation tools; execute validation and collaborate to resolve issues; document unresolved issues (e.g., FDA Data Reviewers Guides).
- Metadata Repository: manage CDISC metadata/terminology libraries; provide governance oversight to ensure metadata consistency.
- Assist in developing data standards policies, procedures and practices.
- Communicate standards concepts and regulatory guidance; represent the Data Standards group in cross-functional initiatives.
- Training & Mentoring: meet training requirements; mentor and train data standards personnel.
- CDISC involvement: manage review comments for public standards; submit at least one abstract per year for CDISC interchange.
Minimum Qualifications:
- B.S.; 12+ years clinical research experience (or 10+ with a Masters).
- Expert knowledge in at least 3 clinical data standards areas (e.g., CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management) and high knowledge in at least one additional area.
- Familiarity with BRIDG, ODM, SHARE.
- Experience mapping/converting legacy data into SDTM domains for eCTD submissions; at least two successful CDISC-compliant submissions.
- Knowledge of international regulations for clinical data standards and regulatory submission datasets.
- Experience with metadata repository technology and data standards governance.
Benefits (if part of job description): paid time off (vacation/holidays/sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.