SDTM Data Standards Lead for Clinical Programming

Initial Therapeutics, Inc.; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie in Irvine is seeking a Manager for Clinical Data and Reporting Standards (CDARS) to lead development and governance of data standards for clinical trials, ensuring CDISC conformance and pipeline SDTM/ADaM development.

You will work with cross-functional experts to create documentation, train teams, and support regulatory submissions with SDTM datasets, define.xml, and CRF feedback, aligning data standards across eCRF, SDTM, and ADaM.

Qualifications

• MS with 8 years of relevant clinical research experience, or
• BS with 10 years of relevant clinical research experience
• Experience with SDTM programming 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

Responsibilities

• Define data standards within therapeutic areas (data collection, data review rules, SDTM mapping).
• Define ADaM mapping, study tables/figures, and product-level safety displays.
• Ensure standards have clear documentation and cross-type consistency.
• Develop training materials and communicate standards across the organization.
• Provide feedback on CRF design and SDTM datasets for regulatory submissions.
• Oversee SDTM datasets, define.xml, annotated CRFs for FDA/PMDA submissions.

Skills

SDTM programming

Data standards development

Regulatory submissions documentation

Education

MS degree in clinical research

BS degree in a relevant field

Job description

AbbVie in Irvine is seeking a Manager for Clinical Data and Reporting Standards (CDARS) to lead development and governance of data standards for clinical trials, ensuring CDISC conformance and pipeline SDTM/ADaM development.

You will work with cross-functional experts to create documentation, train teams, and support regulatory submissions with SDTM datasets, define.xml, and CRF feedback, aligning data standards across eCRF, SDTM, and ADaM.