Principal Statistical Programmer FSP
Tasks
- Create maintain document validate programming standards macros
- Deliver statistical programming results SAS and R programs
- Develop CRFs, edit check specifications, data validation plans
- Develop SAS programs for datasets, listings, tables, graphs
- Follow FDA regulations and good clinical practice for electronic submissions
- Generate SDTM ADaM specifications datasets definexml reviewer guide
- Oversee CRO statistical programming deliverables
- Prepare clinical study reports regulatory submissions publications DSUR exploratory analyses
- Provide review or author data transfer specifications
- Review or author SOPs work instructions statistical programming
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | CDISC | CRF | Clinical Data Interchange Standards | Clinical Data Interchange Standards Consortium | Clinical Practice | Clinical data | Clinical study | Clinical study reports | Data Validation | Define.xml | Edit checks | FDA Regulations | Good Clinical Practice | ICH | Macros | R | Regulatory Submissions | SAS | SDTM | Study Reports
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