- Remote, United States
- Remote
- Full-time · Senior
- 5+ years
The Senior Statistical Programmer supports the analysis and reporting of complex clinical data across clinical trials, real-world evidence (RWE), and observational studies for medical devices.
Responsibilities
- Contribute to development of the SAP, proposing analysis approaches in collaboration with the clinical data scientist
- Independently define, develop, and validate TLF specifications and shells
- Write, maintain, and review programs (primarily SAS) to generate analysis datasets and TLFs
- Execute programs and independently troubleshoot and resolve programming and data issues
- Incorporate TLF outputs into CSRs and other downstream deliverables
Requirements
- Bachelor’s or Master’s degree in a relevant technical field (e.g., statistics, computer science, mathematics, data science, or epidemiology)
- Nice to have: clinical study reports
- Nice to have: regulatory submissions
- Nice to have: FDA and Global regulatory guidelines
- Nice to have: ISO 14155