Clinical Data Standards Lead (SDTM/ADaM)

AbbVie; Illinois; On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance of data standards across CDISC domains (CDASH/SDTM/ADaM) and support regulatory submissions. You will lead cross-functional teams, develop documentation, and deploy training materials to ensure consistency across study-level and product-level data activities.

The role requires MS or BS with extensive clinical research experience, SDTM expertise, and a track record of leading standards development for data

Qualifications

• MS with extensive clinical research experience; knowledge of SDTM required.
• Experience leading development of data standards for collection, tabulation, analysis and reporting.
• Experience with regulatory submissions and CDISC standards in a regulated environment.

Responsibilities

• Lead development and governance of data standards (CDASH/SDTM/ADaM) across therapeutic areas.
• Develop documentation and training materials to enable consistent data handling in pipeline activities.
• Engage cross-functional SMEs to define standards and ensure alignment with regulatory expectations.
• Oversee SDTM datasets, define.xml and related deliverables for regulatory submissions.

Skills

Clinical research

SDTM

CDISC standards

Regulatory submissions

Data governance

Education

MS or BS in a relevant field

Bachelor's in a related field

Tools

CDASH

ADaM

TLF standards

Job description

AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance of data standards across CDISC domains (CDASH/SDTM/ADaM) and support regulatory submissions. You will lead cross-functional teams, develop documentation, and deploy training materials to ensure consistency across study-level and product-level data activities.

The role requires MS or BS with extensive clinical research experience, SDTM expertise, and a track record of leading standards development for data