Principal Statistical Programmer FSP
Tasks
- Author review data transfer specifications
- Create maintain document validate programming standards tools outputs macros
- Develop CRFs, edit check specifications, data validation plans
- Develop SAS programs for datasets, listings, tables, graphs
- Develop validate maintain SAS and R programs
- Follow FDA regulations and good clinical practice
- Generate SDTM ADaM specifications datasets reviewer guide define xml files
- Oversee CRO statistical programming deliverables
- Prepare clinical study reports regulatory submissions publications DSUR exploratory analyses
- Review author SOPs work instructions
Perks/Benefits
Skills/Tech-stack
CDISC | CDISC ADaM | CDISC SDTM | CDISC Terminology | CRF development | Clinical Practice | Clinical Study Reporting | Clinical Trial Methodology | Clinical data | Clinical data standards | Clinical study | Clinical trial | Data Standards | Data Validation | Define.xml | Edit checks | Electronic submissions | FDA Regulations | Git | Good Clinical Practice | ICH Guidelines | Python | R | Regulatory Submissions | SAS | Shiny | Study reporting | Trial methodology | Unix/Linux
Education
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