DM Programmer
Core
Generate Data Management listings from raw clinical trial data and develop or quality control SDTM datasets for individual studies and pooled analyses.
Role type
Data Management Programmer (Clinical Research)
Builds
CDISC SDTM datasets, Define.xml, SDRG documentation
Domain
Clinical research / Biometrics
Required skills
SAS programming, CDISC SDTM standards (v3.3/v3.4), Pinnacle 21 validation tools, protocol deviation reporting, Define.xml generation, SDRG documentation
Preferred skills
Experience with pooled analyses, experience with IDMC reviews, experience with DSURs
Technologies
SAS, Pinnacle 21, Define.xml, SDRG
Responsibilities
Generate Data Management listings and support protocol deviation reporting; Develop or quality control SDTM datasets; Produce and review Define.xml and SDRG documentation; Support key clinical milestones including Dry Runs, Interim Analyses, IDMC reviews, DSURs and Final Analyses; Ensure all deliverables comply with sponsor SOPs, processes and quality standards.
Seniority
Mid-level, hands-on IC
