Principal Statistical Programmer FSP (NONMEM/POPPK Analysis)
Tasks
- Contribute to programming standards documentation and validation
- Create define xml files
- Develop CRFs edit check specifications
- Develop SAS programs for datasets
- Develop SAS programs for tables listings and graphs
- Develop and validate SAS or R programs
- Develop data validation plans
- Ensure submission timelines
- Follow FDA regulations for clinical trial reporting
- Generate ADaM specifications
- Generate SDTM specifications
- Maintain SAS and R programs
- Oversee CRO statistical programming deliverables
- Perform exploratory analyses
- Prepare clinical study reports
- Prepare regulatory submissions
- Review and author SOPs and work instructions
- Review and author data transfer specifications
- Support publications and DSUR
Perks/Benefits
- N/A
Skills/Tech-stack
Biometrics | CDISC ADaM | CDISC SDTM | CRF | Clinical data | Clinical data standards | Clinical trial | Clinical trial reporting | Data Standards | Data Validation | Data transfer | Data transfer specifications | Define-XML | Edit checks | FDA Regulations | Git | ICH GCP | NCA | Nonmem | Pharmacokinetics | Poppk | R | S&OP | SAS | Trial reporting | Unix/Linux
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