Principal Statistical Programmer FSP
Tasks
- Create maintain document validate programming standards macros
- Develop CRFs, edit check specifications, data validation plans
- Develop SAS programs for tables listings graphs
- Develop validate maintain SAS and R programs
- Follow FDA regulations and ICH good clinical practice
- 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
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Biostatistics | CDISC | CRF | Clinical Practice | Clinical Study Reporting | Clinical data | Clinical data standards | Clinical study | Clinical trials | Data Standards | Data Validation | Define.xml | Edit checks | FDA | Git | Good Clinical Practice | ICH | Macros | Pharmacokinetics | R | Regulatory Submissions | SAS | SDTM | Study reporting | UnixLinux
Education
N/A
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