SDTM Data Standards Manager – Regulatory Submissions

Allergan; South San Francisco (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance and deployment of data standards across clinical trials, ensuring conformance to CDISC and industry best practices including SDTM and ADaM.

You will lead cross-functional teams to define data collection, SDTM mapping, ADaM derivation, and reporting standards, while developing training materials and communicating progress across the organization.

Qualifications

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

Responsibilities

• Participate in defining standard types within therapeutic areas: Data Collection, Data Review Rules, SDTM mapping
• Define ADaM mapping and study-level tables, listings or figures
• Develop training materials on standards and communicate development activities across the organization
• Oversee creation of SDTM datasets, define.xml, annotated CRFs for regulatory submissions
• Consult on conformance issues for SDTM/ADaM and coordinate resolutions with study teams

Skills

SDTM programming

Data standards development

Cross-functional leadership

Education

MS in clinical research or related field

BS in life sciences with 10+ years experience

Tools

CDASH

ADaM

TLF standards

Job description

AbbVie seeks a Manager, Clinical Data and Reporting Standards (CDARS) to drive governance and deployment of data standards across clinical trials, ensuring conformance to CDISC and industry best practices including SDTM and ADaM.

You will lead cross-functional teams to define data collection, SDTM mapping, ADaM derivation, and reporting standards, while developing training materials and communicating progress across the organization.