Principal Statistical Programmer FSP
Tasks
- Automate and optimize clinical programming workflows
- Develop and maintain R programs for clinical trials
- Develop and maintain SAS utility programs and tools
- Develop review and approve documentation for regulatory submissions
- Document and maintain validation records for R programs
- Ensure compliance with SOPs and FDA ICH GCP
- Generate TLFs using R tools
- Implement statistical methods with biostatistics and data management
- Integrate or migrate SAS workflows into R environments
- Lead SAS programming for clinical trial analysis and reporting
- Lead technical meetings with stakeholders
- Maintain study documentation and validation records
- Perform QC and validation of R outputs
- Perform QC and validation of SAS programs
- Review define.xml and ADaM Reviewers Guides
- Support reproducible research workflows using R Markdown and Quarto
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Base SAS | CDISC | CDISC SDTM | Data Manipulation | Data Visualization | Define.xml | Dplyr | Ggplot2 | Quarto | R | R Markdown | RMarkdown | Rtables | SAS | SAS Graph | SAS Macro | SAS Stat | Tidyr | Tidyverse
Education
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