Principal Statistical Programmer FSP - Oncology
Tasks
- Create and validate programming standards
- Create listings tables and graphs
- Develop CRF and edit check specifications
- Develop and maintain R programs
- Develop data validation plans
- Develop definexml
- Develop validate and maintain SAS programs
- Ensure FDA compliance
- Generate ADaM specifications
- Generate SDTM specifications
- Implement SAS programs for clinical datasets
- Oversee CRO statistical programming deliverables
- Review author SOPs and work instructions
- Review data transfer specifications
- Support clinical study reports
- Support publications
- Support regulatory submissions
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | CDISC | CRF | Clinical Data Interchange Standards Consortium | Clinical Practice | Clinical Trial Methodology | Clinical data | Clinical trial | Data Validation | Define.xml | Edit checks | Electronic submissions | FDA Regulations | Git | Good Clinical Practice | ICH Guidelines | Markdown | Medical terminology | R | Regulatory Submissions | SAS | SDTM | Shiny | Trial methodology | Unix/Linux
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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