Lead, Clinical Data Standards & SDTM Reporting

AbbVie; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive the development and governance of data and reporting standards across Abbvie's clinical trial portfolio. The role emphasizes SDTM/ADaM design, SDTM programming, and documentation for regulatory submissions.

The candidate will lead cross-functional teams to define data collection, review rules, and trial-level reporting displays, while ensuring consistency with eCRF and CDISC standards.

Qualifications

• Experience with SDTM required and demonstrated history of standard development.
• Ability to lead data collection, tabulation, analysis, and reporting standards.
• Experience preparing SDTM/ADaM datasets for regulatory submissions.
• CDISC/CDASH familiarity is preferred.

Responsibilities

• Develop data and reporting standards in support of AbbVie's clinical trials.
• Govern SDTM/ADaM frameworks and ensure alignment with industry best practices.
• Create training materials on standards use for pipeline teams.
• Communicate ongoing standard development activities across the organization.
• Oversee SDTM datasets, define.xml, annotated CRFs for submissions.

Skills

SDTM experience

ADaM mapping

Data collection standards

Regulatory submissions

CDASH familiarity

Education

MS with 8+ years clinical research experience

BS with 10+ years clinical research experience

Job description

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive the development and governance of data and reporting standards across Abbvie's clinical trial portfolio. The role emphasizes SDTM/ADaM design, SDTM programming, and documentation for regulatory submissions.

The candidate will lead cross-functional teams to define data collection, review rules, and trial-level reporting displays, while ensuring consistency with eCRF and CDISC standards.