SDTM Data Standards Manager - Clinical Submissions

ABBVIE; Irvine (CA); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to lead development and governance of SDTM/ADaM standards for clinical trials, ensuring regulatory conformance and contributing to pipeline data strategy.

You will partner with cross-functional teams, create documentation, training materials, and deliver SDTM datasets, define.xml, CRFs, and study-level tables for FDA/PMDA submissions.

Qualifications

• MS with 8 years of relevant clinical research experience or BS with 10 years of relevant clinical research experience.
• Experience with SDTM programming is required.
• Experience leading development of standards for data collection, tabulation, analysis and/or reporting.
• Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.

Responsibilities

• Develop and govern data and reporting standards for clinical trials in alignment with CDISC CDASH, SDTM and ADaM.
• Create documentation, training materials, and governance processes for standards deployment.
• Contribute to SDTM programming and trial data deliverables including define.xml and study-level outputs.
• Collaborate with cross-functional teams to ensure consistency across standard types and regulatory readiness.
• Represent AbbVie in industry standards projects and stay current with regulatory requirements.

Skills

SDTM programming

CDISC standards

Education

MS in clinical research

BS in related field

Tools

SDTM tooling

Job description

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to lead development and governance of SDTM/ADaM standards for clinical trials, ensuring regulatory conformance and contributing to pipeline data strategy.

You will partner with cross-functional teams, create documentation, training materials, and deliver SDTM datasets, define.xml, CRFs, and study-level tables for FDA/PMDA submissions.