Principal Statistical Programmer FSP
Tasks
- Conduct exploratory analyses
- Create and validate programming standards
- Create define.xml files
- Develop CRFs and edit check specifications
- Develop SAS programs
- Develop data validation plans
- Follow FDA regulations
- Generate ADaM specifications
- Generate SDTM specifications
- Maintain SAS and R programs
- Oversee CRO statistical programming deliverables
- Prepare DSUR
- Prepare clinical study reports
- Review and author SOPs
- Review and author data transfer specifications
- Review and author work instructions
- Support publications
- Support regulatory submissions
- Validate statistical programming outputs
Perks/Benefits
Skills/Tech-stack
ADaM | CDISC | CRF | Clinical Practice | Clinical study | Clinical study report | Data Validation | Data transfer | Define.xml | Edit Check | Edit Check Specifications | Electronic submissions | FDA Regulations | Git | Good Clinical Practice | ICH | Markdown | Python | R | Regulatory Submissions | S&OP | SAS | SDTM | Shiny | Unix/Linux
Education
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