Senior Statistical Programmer (SDTM)
Tasks
- Apply IMWG assessment methods
- Apply RECIST assessment methods
- Collaborate with biostatisticians and sponsors
- Coordinate study start up
- Develop and review trial design domains
- Develop reusable macros
- Ensure CDISC standards compliance
- Ensure ICH GCP compliance
- Improve programming processes
- Perform SDTM programming quality control
- Program SDTM datasets
- Provide technical guidance and mentoring
- Recommend SDTM mapping strategies
- Review protocols and SAPs
- Serve as SDTM lead
- Support data import and export
- Troubleshoot and debug SAS macros
Perks/Benefits
- Global cross-functional collaboration
- Mentoring and knowledge sharing
- Process improvement opportunities
- Professional development
- Remote work opportunity
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | Analysis Plans | CDISC | CFR Part 11 | Clinical data | Clinical data standards | Data Mapping | Data Standards | ICH GCP | IMWG | Part 11 | RECIST | SAS | SAS Macros | SDTM | SDTM mapping | Statistical Analysis | Statistical analysis plans | System life cycle | Trial design | Trial design domains
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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