Senior/Principal Statistical Programmer FSP (SAS + R)
Tasks
- Conduct exploratory analyses
- Create data validation plans
- Create define.xml files
- Create programming standards documentation and validation
- Develop CRFs
- Develop R programs for clinical development
- Develop SAS programs for datasets, listings, tables, graphs
- Develop SAS programs with inferential statistics
- Develop and validate macros
- Develop edit check specifications
- Ensure programming timelines
- Follow FDA regulations
- Generate ADaM specifications
- Generate SDTM specifications
- Oversee CRO programming deliverables
- Prepare annual DSUR
- Prepare clinical study reports
- Review author data transfer specifications
- Review author work instructions
- Review/author SOPs
- Support electronic submissions guidelines
- Support publications
- Support regulatory submissions
- Validate and maintain SAS programs
Perks/Benefits
Skills/Tech-stack
ADaM | Biostatistics | CDISC | CRF | Clinical Practice | Clinical data | Clinical data standards | Clinical study | Clinical study reports | Clinical trials | DSUR | Data Standards | Data Validation | Data transfer | Define.xml | Edit checks | Electronic submissions | FDA Regulations | Good Clinical Practice | ICH | Macros | Medical terminology | R | Regulatory Submissions | S&OP | SAS | SDTM | Study Reports | Work instructions
Education
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