Clinical Data Configurator

5 days ago

Are, India SIRO Full time

Create and/ or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS/ISE) datasets
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
Provide support in developing ad hoc reports as required
Maintain quality and timelines of programming related deliverables
Update project related documentation regularly
Track and follow up on all issues raised.
Experience with R Programming/ Python

Senior Clinical Data Specialist