Senior Manager, Clinical Data Standards & Reporting

Allergan; South San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to lead governance and deployment of SDTM/ADaM data standards across clinical trials. You will collaborate with cross-functional teams to define data collection, review rules, SDTM mapping, and trial design domains, ensuring regulatory compliance.

The role includes developing training materials, communicating ongoing standard development, and guiding SDTM/ADaM program activities in support of pipeline submissions.

Qualifications

• Requires MS or BS with extensive clinical research experience and SDTM knowledge.
• Demonstrated ability to lead development of data standards for collection, tabulation, analysis and reporting.
• Experience preparing SDTM/ADaM datasets and documentation for regulatory submissions.

Responsibilities

• Develop and govern data standards across SDTM, ADaM, CDASH, and related areas.
• Ensure standard definitions have clear documentation and align across data types (eCRF, SDTM, ADaM).
• Create training materials and communicate progress of standards development.
• Provide feedback on CRF design and SDTM datasets to support regulatory requirements.

Skills

SDTM is required

Standard development experience

Regulatory submissions support

Education

MS with 8 years of relevant clinical research experience

BS with 10 years of relevant clinical research experience

Job description

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to lead governance and deployment of SDTM/ADaM data standards across clinical trials. You will collaborate with cross-functional teams to define data collection, review rules, SDTM mapping, and trial design domains, ensuring regulatory compliance.

The role includes developing training materials, communicating ongoing standard development, and guiding SDTM/ADaM program activities in support of pipeline submissions.