Associate Director - Data Standards (Hybrid)
AbbVie
August 06, 2026
Remote friendly (Florham Park, NJ)
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; track industry trends
- Review eCRF designs for conformance with CDASH/SDTM; identify and proactively correct flaws
- Review SDTM conformance mapping specifications; provide CDISC expertise for cross-functional mapping from source data to SDTM
- Execute and interpret results from CDISC validation tools (define.xml for SDTM/ADaM); resolve issues and document unresolved items
- Manage CDISC-related metadata/terminology standards in the metadata repository; provide governance oversight to ensure consistency
- Assist in developing data standards policies, procedures and practices
- Communicate clinical data standards concepts and regulatory guidance; represent Data Standards group in cross-functional initiatives
- Mentor/train data standards teams; ensure training compliance
- Support CDISC public review processes and submit at least one abstract per year for a CDISC Interchange
Qualifications:
- B.S.
- 12+ years clinical research experience (or 10+ with a Masters)
- Expert knowledge in at least 3 areas of clinical data standards (e.g., CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management) plus high knowledge in one additional area
- Familiar with BRIDG, ODM, SHARE
- Experience mapping/converting legacy data to SDTM for eCTD; at least two successful CDISC-compliant submissions
- Knowledge of international regulations/guidance for clinical data standards and regulatory datasets
- Experience with metadata repository technology and data standards governance; experience managing metadata for efficient system/process use
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; track industry trends
- Review eCRF designs for conformance with CDASH/SDTM; identify and proactively correct flaws
- Review SDTM conformance mapping specifications; provide CDISC expertise for cross-functional mapping from source data to SDTM
- Execute and interpret results from CDISC validation tools (define.xml for SDTM/ADaM); resolve issues and document unresolved items
- Manage CDISC-related metadata/terminology standards in the metadata repository; provide governance oversight to ensure consistency
- Assist in developing data standards policies, procedures and practices
- Communicate clinical data standards concepts and regulatory guidance; represent Data Standards group in cross-functional initiatives
- Mentor/train data standards teams; ensure training compliance
- Support CDISC public review processes and submit at least one abstract per year for a CDISC Interchange
Qualifications:
- B.S.
- 12+ years clinical research experience (or 10+ with a Masters)
- Expert knowledge in at least 3 areas of clinical data standards (e.g., CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management) plus high knowledge in one additional area
- Familiar with BRIDG, ODM, SHARE
- Experience mapping/converting legacy data to SDTM for eCTD; at least two successful CDISC-compliant submissions
- Knowledge of international regulations/guidance for clinical data standards and regulatory datasets
- Experience with metadata repository technology and data standards governance; experience managing metadata for efficient system/process use