SDTM Data Standards Manager — Clinical Data & Reporting

PowerToFly; North Chicago (IL); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance of data standards across clinical trials, ensuring SDTM/ADaM conformance and industry best practices. You will deploy next‑generation processes and lead cross‑functional collaboration to advance data quality and reporting across therapeutic areas.

You will oversee SDTM datasets, define.xml and submission materials for regulatory bodies, and develop training to standardize practices, while remaining current

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

• Define data standards within therapeutic areas and document assumptions and decisions.
• Develop SDTM mappings and ADaM derivations and trial-level outputs.
• Oversee SDTM datasets, define.xml, annotated CRF and submission materials for regulatory submissions.
• Ensure consistency across SDTM/ADaM and related standards; develop training materials.
• Represent AbbVie in industry standards development projects and stay current with CDISC guidance

Skills

SDTM programming

ADaM mapping

Regulatory submissions

Cross-functional leadership

Education

MS in Clinical Research

BS in Life Sciences

Job description

AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance of data standards across clinical trials, ensuring SDTM/ADaM conformance and industry best practices. You will deploy next‑generation processes and lead cross‑functional collaboration to advance data quality and reporting across therapeutic areas.

You will oversee SDTM datasets, define.xml and submission materials for regulatory bodies, and develop training to standardize practices, while remaining current