Principal Statistical Programmer FSP
Tasks
- Author data transfer specifications
- Contribute DSUR preparation
- Create SAS tables listings and graphs
- Create and maintain programming macros
- Create data validation plans
- Develop CRFs
- Develop Define xml files
- Develop SAS programs for clinical trials
- Develop and validate SAS programs
- Develop and validate programming tool standards
- Develop edit check specifications
- Develop reviewer guide
- Ensure reporting timeline compliance
- Follow FDA regulations
- Follow Good Clinical Practice
- Generate ADaM specifications
- Generate SDTM specifications
- Implement SAS datasets
- Maintain SAS and R programs
- Oversee CRO statistical programming deliverables
- Perform exploratory analyses
- Prepare clinical study reports
- Review SOPs for statistical programming
- Support publications
- Support regulatory submissions
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | CDISC | CRF | Clinical Data Interchange Standards | Clinical Data Interchange Standards Consortium | Clinical Practice | Clinical Trial Methodology | Clinical data | Clinical study | Clinical study report | Clinical trial | Data Validation | Data transfer | Data transfer specifications | Define-XML | Edit checks | Electronic submissions | FDA Regulations | Git | Good Clinical Practice | ICH Guidelines | Medical terminology | Programming macros | R | Regulatory Submissions | SAS | SDTM | Trial methodology | Unix/Linux | XML
Education
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