Clinical Data Configurator

3 weeks ago


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



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