Clinical Data Standards & SDTM Lead

ABBVIE; Florham Park (NJ); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie in Florham Park, NJ, is seeking a Manager of Clinical Data and Reporting Standards (CDARS) to develop and govern data standards for clinical trials in alignment with CDISC and regulatory expectations.

The role involves leading SDTM/ADaM standard development, collaborating with cross-functional teams, and overseeing SDTM datasets, define.xml, and reporting documentation for regulatory submissions. A strong SDTM background and industry standards experience are essential.

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.

Responsibilities

• Actively participate in defining SDTM/ADaM standards within assigned therapeutic areas including data collection, SDTM mapping and ADaM mapping.
• Oversee SDTM datasets, define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for regulatory submissions (FDA/PMDA).
• Consult on conformance issues for SDTM/ADaM and resolve problems with study teams.
• Represent AbbVie in industry standards development projects and stay current with CDISC standards and regulatory requirements.

Skills

SDTM programming

CDISC standards

ADaM mapping

Education

MS with 8 years experience

BS with 10 years experience

Job description

AbbVie in Florham Park, NJ, is seeking a Manager of Clinical Data and Reporting Standards (CDARS) to develop and govern data standards for clinical trials in alignment with CDISC and regulatory expectations.

The role involves leading SDTM/ADaM standard development, collaborating with cross-functional teams, and overseeing SDTM datasets, define.xml, and reporting documentation for regulatory submissions. A strong SDTM background and industry standards experience are essential.