Principal Programmer/Associate Manager - Statistical Programming, Central Services
Tasks
- Coordinate dataset and output delivery for disclosure activities
- Create integrated datasets
- Create pooled analysis datasets
- Create reports and programming documentation
- Develop tools and standard processes
- Ensure compliance with regulatory standards
- Prepare and review electronic data packages
- Respond to programming related inquiries during inspections
- Review and troubleshoot validation reports
- Support inspection readiness activities
- Troubleshoot programming validation and submission issues
Perks/Benefits
Skills/Tech-stack
ADaM | CDISC | Clinical Trial Data | Clinical trial | Data Management | Define-XML | ECTD | Pinnacle 21 | Python | R | Regulatory Submissions | SAS | SAS Base | SAS Graph | SAS Macro | SAS Stat | SDTM | Trial data | Validation
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