Lead SDTM Data Standards & Programming Manager

Allergan; Chicago, Northern (IL, KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Benefits package

Long-term incentives

Paid time off

Job summary

AbbVie in Chicago seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance of SDTM/ADaM data standards across clinical trials and ensure alignment with CDISC.

You will lead cross-functional teams, develop training materials, oversee SDTM datasets and submission deliverables for regulatory bodies, and push continuous improvements in data collection, review rules, and reporting deliverables.

Qualifications

• MS with 8 years of relevant clinical research experience.
• 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

• Actively participates in the development of data and reporting standards in support of AbbVie’s trials.
• Develop governance framework for SDTM/ADaM data standards across therapeutic areas.
• Create training materials on standard usage for pipeline activities.
• Communicate ongoing standard development across the organization.
• Provide feedback on CRF design and SDTM datasets to ensure regulatory compliance.

Skills

SDTM programming

Data standards

CDASH knowledge

ADaM

Regulatory submissions

Education

MS with 8 years clinical research experience

BS with 10 years clinical research experience

Job description

AbbVie in Chicago seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance of SDTM/ADaM data standards across clinical trials and ensure alignment with CDISC.

You will lead cross-functional teams, develop training materials, oversee SDTM datasets and submission deliverables for regulatory bodies, and push continuous improvements in data collection, review rules, and reporting deliverables.