Clinical Data Science Programmer

• Build and configure studies in CDMS based on protocol requirements.
• Develop and test validation/derivation checks; perform UAT.
• Implement blinding rules and manage TMF‑required documentation.
• Provide technical input on protocol, EDC requirements, and study documents.

• Create DMW trials, mapping specifications, and external data models.
• Perform SDTM staging/model transformations and execute data loads.
• Configure filewatchers and update transformations as needed.
• Review eCRFs and DCM annotations to ensure metadata alignment.

• Map data across CDMS → DMW → CDW → SCE for SDTM dataset generation.
• Develop, validate, and QC programs supporting data accuracy and reporting.
• Support define.xml, aCRF, SDRG, and final SDTM package preparation.

• Share best practices, lessons learned, and contribute to standards adoption.
• Support process optimization, documentation updates, and change management.
• Collaborate with cross‑functional teams to enhance efficiency and automation.

• Partner with Data Managers, Biostats, IT, Central Monitoring, and external CROs/vendors.
• Communicate effectively across functions; provide documentation and training as required.
• Resolve technical issues collaboratively and manage conflicting viewpoints professionally.

• M.Sc/B.Sc in Life Science, Computer Science, IT, or related field.
• 5 years’ pharma experience in DMW, LSH, Veeva
• Hands‑on experience with CDASH, CDISC, SDTM, and clinical data systems.
• Strong knowledge of GxP, clinical development processes, and project coordination.
• Experience working with global, cross‑functional teams.

ICON