Principal Statistical Programmer FSP
Tasks
- Author data transfer specifications
- Conduct exploratory analyses
- Create Define xml
- Create and validate programming standards
- Create data validation plans
- Create listings tables and graphs
- Define edit check specifications
- Develop CRFs
- Develop SAS programs
- Develop SOPs and work instructions
- Develop and validate SAS and R programs
- Ensure programming timelines quality
- Follow FDA regulations
- Generate ADaM specifications
- Generate SDTM specifications
- Generate datasets
- Oversee CRO programming deliverables
- Prepare DSUR
- Review CRO data transfer specifications
- Support clinical study reports
- Support publications
- Support regulatory submissions
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Biostatistics | CDISC | CRF | Clinical Practice | Clinical Trial Methodology | Clinical data | Clinical data standards | Clinical trial | Data Standards | Data Validation | Define-XML | Edit checks | Electronic submissions | FDA Regulations | Git | Good Clinical Practice | ICH Guidelines | Markdown | Medical terminology | Python | R | SAS | SDTM | Shiny | Trial methodology | Unix Shell | Unix/Linux
Education
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