Senior Statistical Programmer/Analyst III is responsible for annotating case report forms, developing SDTM and ADaM datasets, and creating electronic submission packages to FDA. The role requires expert-level skills in programming languages such as SAS, C/C++, Java, R, Python, MATLAB, and SQL, as well as knowledge of ICH, Good Clinical Practices, and clinical research.
Requirements
- Bachelor's/Master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines
- 5+ years of clinical programming experience
- Proven knowledge and training in high-level computing languages such as SAS, C/C++, Java, R, Python, MATLAB, and SQL
- Expert-level skills in decoding programming logic and assembling programming code
- In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
- Strong communication skills and coordination skills; ability to communicate with global teams independently