Principal Statistical Programmer FSP
Tasks
- Contribute to programming standards
- Create CRF specifications
- Create data transfer specifications
- Create define xml files
- Create edit check specifications
- Define data validation plans
- Develop SAS datasets
- Develop SAS programs
- Develop define and output macros
- Follow FDA regulations
- Generate ADaM specifications
- Generate SDTM specifications
- Oversee CRO statistical programming deliverables
- Perform exploratory analyses
- Prepare clinical study reports
- Produce clinical listings tables and graphs
- Review SOPs and work instructions
- Support DSUR
- Support clinical trial data reporting
- Support publications
- Support regulatory submissions
- Validate and maintain SAS programs
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Biometrics | Biostatistics | CDISC | CRF | Clinical Data Interchange Standards | Clinical Data Interchange Standards Consortium | Clinical Practice | Clinical data | Clinical study | Clinical study reports | Clinical trial | Clinical trial methodologies | Data Validation | Define.xml | Edit checks | FDA Regulations | Git | Good Clinical Practice | ICH Guidelines | Java | Python | R | Regulatory Submissions | SAS | SDTM | Shiny | Unix/Linux
Education
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