Principal Statistical Programmer FSP
Tasks
- Author data transfer specifications
- Contribute to programming standards and macros
- Create define xml files
- Create reviewer guide
- Develop CRFs edit check specifications and data validation plans
- Develop R programs
- Develop SAS programs
- Develop SDTM and ADaM datasets
- Develop and validate statistical programming deliverables
- Follow FDA regulations and good clinical practice
- Generate SDTM and ADaM specifications
- Generate listings tables and graphs
- Maintain and validate SAS and R programs
- Oversee CRO programming deliverables
- Review and author SOPs and work instructions
- Support DSUR preparation
- Support clinical study reports
- Support exploratory analyses
- Support publications
- Support regulatory submissions
Perks/Benefits
Skills/Tech-stack
ADaM | CDISC | Clinical Practice | Clinical data | Clinical data management | Clinical study | Clinical study reports | Data Management | Define-XML | FDA | Good Clinical Practice | Macros | R | Regulatory Submissions | SAS | SDTM | Statistical programming
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