Principal Statistical Programmer FSP
Tasks
- Apply Good Clinical Practice
- Author data transfer specifications
- Contribute annual DSUR
- Create and validate programming tools standards
- Create reviewer guide
- Define definexml files
- Develop CRFs and edit check specifications
- Develop SAS programs for datasets, listings, tables, and graphs
- Develop and validate SAS programs
- Develop data validation plans
- Develop programming macros standards
- Ensure programming timelines and quality
- Follow FDA regulations for clinical trial reporting
- Generate ADaM specifications
- Generate SDTM specifications
- Maintain SAS and R programs
- Oversee CRO statistical programming deliverables
- Perform exploratory analyses
- Review SOPs and work instructions
- Review and author SOPs for statistical programming practices
- Support clinical study reports
- Support publications
- Support regulatory submissions
Perks/Benefits
Skills/Tech-stack
ADaM | Biometrics | CDISC | CRF | CRO oversight | Clinical Development | Clinical Practice | Clinical Trial Methodology | Clinical trial | Data Validation | DefineXML | Edit checks | Electronic submissions | FDA Regulations | Git | Good Clinical Practice | ICH Guidelines | Java | Markdown | Medical terminology | Python | R | Regulatory Submissions | S&OP | SAS | SDTM | Shiny | Trial methodology | Unix/Linux | Work instructions
Education
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