Your main activities as CMC statistician will be :
- Statistical Support for Development: Involved in all stages of projects (from preclinical to clinical phases 1, 2, 3, and marketed products).
- Managing Multiple Requests: Handle several requests simultaneously, which may last from a few hours to several days, depending on complexity.
- Data Analysis and Reporting: Perform detailed statistical analyses and write corresponding reports. Some analyses may be reviewed by another statistician.
- Use of R and SAS: Proficiency in R and SAS software for data processing and statistical code tracking.
- Quality Monitoring and Methodology: Collaborate closely with scientists to ensure the quality of work and the application of appropriate statistical methods, particularly through Design of Experiments (DOE).
- Collaboration with Internal Departments: Interact with various departments such as development, manufacturing, and commercial to meet statistical needs, ask the right questions, and ensure the relevance of analyses.