Senior Statistical Programmer - Remote
Tasks
- Apply SDLC for programming deliverables
- Create SDTM specifications
- Develop SAS macros
- Ensure compliance with 21 CFR Part 11 and ICH standards
- Generate tables listings and graphs
- Lead study or small programming project teams
- Pool datasets for submissions
- Prepare ESubmission outputs
- Program clinical trial deliverables
- Support ADaM specifications
- Support define xml Reviewers Guides SDSP
- Write SAS Base code
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | BIMO | CFR Part 11 | Clinical Trial Data | Clinical trial | Data submission | Define-XML | Electronic Data | Electronic data submission | ICH | ISO 27001 | ISO 9001 | MS Office | Part 11 | Pooling | Reviewers Guide | SAS | SAS Base | SAS Macros | SDLC | SDSP | SDTM | Trial data
Education
Roles
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