Create and / or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS / ISE) datasets
Create visualizations
Experience with Principal SQL + Elluminate
Experience with R Programming / Python
Perform development and validation of analysis dataset, tables, listings and figures for both safety and efficacy parameters
Understand and comply with ICH-GCP guidelines, core operating procedures and work instructions.
Ensure all programs are compliant with the SOPs and project specific guidelines
Maintain quality and timelines of programming related deliverables
Update project related documentation regularly
Track and follow up on all issues raised.
Clinical Data Programmer • Kolkata, West Bengal, India