SDTM Data Standards Leader

BioSpace; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

PTO & Holidays

Medical/Dental/Vision Insurance

401(k) & Benefits

Long-term Incentive Programs

Job summary

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance and deployment of data standards across AbbVie's clinical trials. You will lead SDTM/ADaM mappings, data collection rules, and study-level tables while ensuring conformance to CDISC standards and regulatory expectations.

The role requires cross-functional collaboration, development of training materials, and ongoing communication of standards initiatives to the organization.

Qualifications

• Experience leading development of data standards for collection, tabulation, analysis and reporting.
• Experience preparing SDTM/ADaM datasets and documentation for regulatory submissions.
• Strong collaboration with cross-functional teams to align standards across SDTM, ADaM and CDASH.

Responsibilities

• Participate in cross-functional teams to define data standards within therapeutic areas (e.g., data collection, data review rules, SDTM/ADaM mappings).
• Oversee SDTM datasets, define.xml, annotated CRFs, and study data reviewers guides for regulatory submissions (FDA/PMDA).
• Provide guidance on conformance issues for SDTM/ADaM and resolve data/metadata issues with study teams.

Skills

SDTM programming

CDISC standards

Data governance

Education

MS in clinical research

BS in clinical research

Job description

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance and deployment of data standards across AbbVie's clinical trials. You will lead SDTM/ADaM mappings, data collection rules, and study-level tables while ensuring conformance to CDISC standards and regulatory expectations.

The role requires cross-functional collaboration, development of training materials, and ongoing communication of standards initiatives to the organization.