Principal Statistical Programmer FSP
Tasks
- Author SOPs for statistical programming
- Conduct exploratory analyses
- Contribute to standards and programming tools validation
- Develop CRFs
- Develop Define xml files
- Develop SAS datasets
- Develop SAS graphs
- Develop SAS listings
- Develop SAS tables
- Develop and validate R programs
- Develop and validate SAS programs
- Develop data validation plans
- Develop edit check specifications
- Ensure consistent high quality outputs
- Follow FDA regulations for clinical trial reporting
- Generate ADaM specifications
- Generate SDTM specifications
- Oversee CRO statistical programming deliverables
- Prepare annual DSUR
- Prepare clinical study reports
- Review data transfer specifications
- Support publications
- Support regulatory submissions
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Biostatistics Programming | CDISC | CRF | Clinical Study Reporting | Clinical study | Clinical trial | Clinical trial reporting | Data Validation | Data transfer | Data transfer specifications | Define-XML | Edit checks | FDA Regulations | GCP | Git | ICH | Pharmacokinetics | Python | R | Regulatory Submissions | S&OP | SAS | SDTM | Study reporting | Trial reporting | Unix/Linux
Education
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