S
Clinical Data Configurator
SIRO
Amravati · On-site Full-time Today
About the role
Responsibilities
- 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.
Requirements
- Experience with R Programming/ Python
Responsibilities
- 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.
Skills
PythonR Programming
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