Senior Manager, Clinical Data Standards & SDTM

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

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie seeks a Manager for Clinical Data and Reporting Standards to drive data and reporting standards across clinical trials, aligning CDISC SDTM/ADaM and AbbVie extensions. You will define governance for standards and deploy next-generation processes and technology.

The role entails collaboration with cross-functional teams, development of training materials, and ensuring consistency across standard types to support pipeline activities and regulatory submissions.

Qualifications

• 8+ years of clinical research experience with MS or 10+ years with BS.
• Experience with SDTM is required.
• Experience leading standards for data collection, tabulation, analysis or reporting.
• Experience preparing SDTM/ADaM datasets and documentation for regulatory submissions.

Responsibilities

• Define standards for data collection, review rules, and SDTM mapping.
• Define ADaM mapping, study tables, listings, or figures.
• Ensure standards are documented and aligned across types (e.g., SDTM vs ADaM).
• Develop training materials on standards for organization use.
• Oversee SDTM datasets, define.xml, annotated CRF and Study Data Reviewer’s Guides for submissions.
• Consult on conformance issues and provide explanations.

Skills

Leadership

Regulatory knowledge

Documentation

Cross-functional collaboration

Education

MS with 8+ years clinical research

BS with 10+ years clinical research

Tools

SDTM

ADaM

CDISC standards

Job description

AbbVie seeks a Manager for Clinical Data and Reporting Standards to drive data and reporting standards across clinical trials, aligning CDISC SDTM/ADaM and AbbVie extensions. You will define governance for standards and deploy next-generation processes and technology.

The role entails collaboration with cross-functional teams, development of training materials, and ensuring consistency across standard types to support pipeline activities and regulatory submissions.