Principal Statistical Programmer FSP
Tasks
- Build SAS datasets
- Contribute to CRF development
- Contribute to edit check specifications
- Create SAS graphs
- Create SAS listings
- Create SAS tables
- Create and validate programming standards
- Create define.xml files
- Develop ADaM specifications
- Develop SDTM and ADaM processes
- Develop data validation plans
- Develop macros for statistical programming
- Develop reviewer guide
- Follow FDA regulations
- Generate SDTM specifications
- Oversee CRO statistical programming deliverables
- Prepare clinical study reports
- Review SOPs and work instructions
- Review author data transfer specifications
- Support CRO timeline delivery
- Support DSUR preparation
- Support electronic submissions guidelines
- Support exploratory analyses
- Support regulatory submissions
- Validate and maintain SAS programs
Perks/Benefits
Skills/Tech-stack
ADaM | CDISC | Clinical Trial Methodology | Clinical data | Clinical data standards | Clinical trial | Data Standards | DefineXML | Electronic submissions | FDA Regulations | Git | ICH Guidelines | Medical terminology | Neuroscience | Pharmacokinetics | Python | R | SAS | SDTM | Shiny | Trial methodology | UnixLinux
Education
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