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 programs
- Follow FDA regulations good clinical practice electronic submissions
- Generate SDTM ADaM specifications datasets reviewer guide define xml
- Oversee CRO statistical programming deliverables
- Review author SOPs work instructions for statistical programming
- Review author data transfer specifications for external vendors
- Support DSUR and exploratory analyses
- Support clinical study report preparation regulatory submissions publications
Perks/Benefits
Skills/Tech-stack
ADaM | CDISC | CRF | Clinical data | Clinical study | Clinical study report | Clinical trial | Clinical trial methodologies | DSUR | Data Validation | Define-XML | Edit checks | FDA Regulations | Git | ICH GCP | Medical terminology | Pharmacokinetics | Python | R | SAS | SDTM | Unix/Linux
Education
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