Principal Statistical Programmer FSP
Tasks
- Author SOPs and work instructions
- Create datasets listings tables and graphs
- Develop CRF edit check specifications
- Develop Define xml files
- Develop SAS programs
- Develop data validation plans
- Develop exploratory analyses
- Develop validate and maintain R programs
- Develop validate and maintain SAS programs
- Follow FDA regulations
- Follow Good Clinical Practice
- Generate ADaM specifications
- Generate SDTM specifications
- Generate reviewer guide
- Implement programming standards macros and outputs
- Oversee CRO statistical programming deliverables
- Review and author data transfer specifications
- Support CRO vendor coordination for timelines
- Support DSUR preparation
- Support clinical study report preparation
- Support publication preparation
- Support regulatory submission preparation
Perks/Benefits
Skills/Tech-stack
CDISC ADaM | CDISC SDTM | CRF | Clinical Practice | Clinical Trial Methodology | Clinical data | Clinical data standards | Clinical study | Clinical study report | Clinical trial | DSUR | Data Standards | Data Validation | Data transfer | Data transfer specifications | Define-XML | Edit checks | Exploratory analysis | FDA Regulations | Git | Good Clinical Practice | ICH Guidelines | Macros | Medical terminology | R | Regulatory Submissions | S&OP | SAS | Trial methodology | Unix/Linux
Education
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