SDTM Data Standards Manager

SmartRecruiters, Inc.; North Chicago (IL); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance of data and reporting standards for AbbVie’s clinical trials. You will implement strategies for CDISC conformance and SDTM/ADaM development, leading cross-functional teams and ensuring regulatory alignment across pipelines.

Responsibilities include defining and documenting standards, training staff, and coordinating with study teams to deliver compliant data products for FDA/PMDA submissions.

Qualifications

• MS/BS with significant clinical research experience and SDTM knowledge.
• Experience leading development of data collection, tabulation, analysis and reporting standards.
• Strong collaboration with cross-functional teams and regulators.

Responsibilities

• Develop and govern data standards for SDTM/ADaM in AbbVie trials.
• Ensure SDTM datasets, define.xml, and study data are regulatory-ready.
• Collaborate with CDISC teams and study teams to drive compliant solutions.
• Create training materials on standards usage for pipeline activities.
• Communicate progress of standard development across the organization.

Skills

SDTM programming

Data standards governance

Regulatory submissions

Education

MS with 8 years of relevant clinical research experience

BS with 10 years of relevant clinical research experience

Job description

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance of data and reporting standards for AbbVie’s clinical trials. You will implement strategies for CDISC conformance and SDTM/ADaM development, leading cross-functional teams and ensuring regulatory alignment across pipelines.

Responsibilities include defining and documenting standards, training staff, and coordinating with study teams to deliver compliant data products for FDA/PMDA submissions.