CMC Statistician

at  HNM Solutions

REQUIREMENTS:

- - Education: Master’s degree in statistics, preferably with a background in mathematics. An engineering degree is also acceptable.
- - Technical Skills: Strong knowledge of statistics, with expertise in DOE (Design of Experiments).
- - Preclinical or clinical knowledge is a plus, but the ability to extend skills beyond specific domains is essential.

EXPERIENCE:

- - Experience in the CMC field is an advantage. Experience in preclinical or clinical statistics is also relevant, but the ability to adapt work methods to a CMC environment is crucial.
- - Autonomy and Curiosity: Strong ability to work independently, dig into client requests, and ask the right questions to go beyond simple statistical analysis.
- - Communication: Excellent communication skills, with the ability to collaborate effectively with scientists and other departments.
- - Languages: Proficiency in English is required; French or Dutch is a MUST.

KEY RESPONSIBILITIES:

- - 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.