Principal Statistical Programmer FSP
Tasks
- Create maintain document validate programming standards macros
- Develop CRFs, edit check specifications, data validation plans
- Develop SAS programs for datasets, listings, tables, graphs
- Develop validate maintain SAS and R programs for clinical development
- Follow FDA regulations good clinical practice electronic submissions
- Generate SDTM ADaM specifications datasets reviewer guide define xml
- Oversee CRO statistical programming deliverables
- Prepare clinical study reports regulatory submissions publications DSUR exploratory analyses
- Review author SOPs work instructions for statistical programming practices
- Review author data transfer specifications for external vendors
Perks/Benefits
Skills/Tech-stack
ADaM | Biostatistics Programming | CDISC | Clinical Practice | Clinical Trial Methodology | Clinical data | Clinical trial | Define-XML | FDA | Git | Good Clinical Practice | ICH | Markdown | Medical terminology | Pharmacokinetics | R | SAS | SDTM | Trial methodology | Unix/Linux
Education
Bachelor of Arts | Bachelor of Engineering | Bachelor of Science
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