Lead SDTM Data Standards & Programming

Biopharma Careers; Florham Park (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie in Florham Park, NJ is seeking a Manager, Clinical Data and Reporting Standards to advance data standards for clinical trials, ensuring SDTM/ADaM conformance and pipeline validation. You will drive governance, develop training, and collaborate with cross‑functional teams to support regulatory submissions.

The role requires leading development of data collection and reporting standards, SDTM mappings, and SDTM/ADaM documentation, with a focus on regulatory readiness and industry best

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

• Provide SDTM datasets and define.xml for regulatory submissions.
• Oversee creation of annotated CRFs and reviewer guides for FDA/PMDA submissions.
• Review SDTM Trial Design Domains and SDTM programming activities.
• Ensure data and metadata conform to CDISC standards and AbbVie extensions.
• Communicate standard development progress to cross-functional teams.

Skills

SDTM programming

Data standards development

Regulatory submissions

Cross-functional collaboration

Data governance

Education

MS in Clinical Research

BS in a related field

Tools

SDTM mapping tools

Job description

AbbVie in Florham Park, NJ is seeking a Manager, Clinical Data and Reporting Standards to advance data standards for clinical trials, ensuring SDTM/ADaM conformance and pipeline validation. You will drive governance, develop training, and collaborate with cross‑functional teams to support regulatory submissions.

The role requires leading development of data collection and reporting standards, SDTM mappings, and SDTM/ADaM documentation, with a focus on regulatory readiness and industry best