Clinical Data Standards Lead (SDTM/CDISC)

BioSpace; South San Francisco (CA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Paid time off & holidays

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Manager, Clinical Data and Reporting Standards to shape data and reporting standards for clinical trials. You will lead cross-functional teams to define SDTM/ADaM standards, ensure regulatory conformance, and support CDISC initiatives.

The role involves developing training materials, guiding SDTM/ADaM datasets, and collaborating with study teams to resolve conformance issues. Strong CDISC experience and regulatory submissions expertise are required.

Qualifications

• Experience with SDTM 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.
• CDISC standards knowledge and regulatory submissions experience is essential.

Responsibilities

• Develop data and reporting standards within therapeutic areas.
• Ensure SDTM/ADaM conformance and CDISC alignment across projects.
• Create training materials on standards use for pipeline activities.
• Oversee SDTM datasets, define.xml, annotated CRFs for regulatory submissions.
• Represent AbbVie's interests in industry standards initiatives.

Skills

SDTM

ADaM

CDISC

Education

MS with 8 years of relevant clinical research experience

BS with 10 years of relevant clinical research experience

Tools

CDASH

Job description

AbbVie is seeking a Manager, Clinical Data and Reporting Standards to shape data and reporting standards for clinical trials. You will lead cross-functional teams to define SDTM/ADaM standards, ensure regulatory conformance, and support CDISC initiatives.

The role involves developing training materials, guiding SDTM/ADaM datasets, and collaborating with study teams to resolve conformance issues. Strong CDISC experience and regulatory submissions expertise are required.