Data Standards Manager – Clinical Trials & SDTM

ABBVIE; South San Francisco (CA); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to lead the development and governance of data and reporting standards across AbbVie’s clinical trials. You will work with cross-functional experts to define SDTM, ADaM, and related standards, ensuring regulatory alignment and quality.

You will also develop training materials, communicate ongoing activities, and support SDTM/ADaM submissions, with emphasis on data quality and standardized reporting across programs.

Qualifications

• Experience with SDTM programming is required.
• Experience leading development of data standards across SDTM/ADaM/CDASH.
• Experience preparing SDTM and/or ADaM datasets for regulatory submissions.

Responsibilities

• Develop and govern data and reporting standards across therapeutic areas.
• Collaborate with cross-functional SMEs to define SDTM, ADaM, and related standards.
• Create training materials and communicate progress on standards.
• Support SDTM trials design, datasets, and submission deliverables.
• Represent AbbVie in industry standards projects.

Skills

SDTM programming

CDISC standards

Regulatory submissions

Education

MS in a relevant field with 8+ years clinical research experience

BS in a relevant field with 10+ years clinical research experience

Job description

AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to lead the development and governance of data and reporting standards across AbbVie’s clinical trials. You will work with cross-functional experts to define SDTM, ADaM, and related standards, ensuring regulatory alignment and quality.

You will also develop training materials, communicate ongoing activities, and support SDTM/ADaM submissions, with emphasis on data quality and standardized reporting across programs.