Principal Statistical Programmer FSP
Tasks
- Create CRFs edit check specifications and data validation plans
- Develop SAS programs for tables listings and graphs
- Develop and validate programming standards and macros
- Ensure FDA good clinical practice compliance
- Generate SDTM, ADaM specifications
- Implement clinical trial datasets and analysis outputs
- Oversee CRO statistical programming deliverables
- Prepare clinical study reports and regulatory submissions
- Review and author data transfer specifications for vendors
- Review and author statistical programming SOPs and work instructions
- Validate and maintain SAS programs and R programs
Perks/Benefits
Skills/Tech-stack
CDISC ADaM | CDISC SDTM | CRF | Clinical Practice | Clinical data | Clinical data standards | Clinical study | Clinical study reports | Clinical trial | Clinical trial methodologies | Data Standards | Data Validation | Define.xml | Edit checks | Electronic submissions | FDA Regulations | Git | Good Clinical Practice | ICH | Macros | R | Regulatory Submissions | SAS | SOPs | Unix/Linux
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