Data Standard Analyst - Biostatistics Team
On-site
Core
Implement data standards and validation for clinical trial data to ensure regulatory compliance for biopharma clients.
Role type
Data Standard Analyst (Biostatistics)
Builds
CDISC SDTM datasets and define packages for regulatory submission
Domain
Clinical Research / Biostatistics / Regulatory Data
Required skills
SAS programming, CDISC SDTM standards, data validation, CRF creation, data reconciliation
Preferred skills
None stated
Technologies
SAS
Responsibilities
Implement edit check specifications via SAS programming; Create annotated CRFs and mapping specifications per CDISC SDTM standards; Create SDTM data via SAS programming; Perform validation of CDISC SDTM data in accordance with SOPs; Ensure SDTM data conforms to regulatory agency standards; Assist with creation of the define package for submission to regulatory agencies.