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Non-clinical CMC Statistician Consultant

Brussels, Belgium

Our well-known client from the field of pharmaceutical is currently looking for a Non-Clinical CMC Statistician Consultant

Your responsibilities

Provides statistical consultancy in relation with analytical methods and control strategy for continuous manufacturing (method/process transfer and validation, product homogeneity, process optimization and control).

The person will be responsible for designing the experiments, analyzing the data, and writing reports and/or presentations for internal and/or external clients, including Regulatory Authorities. She/he will also develop/give training packages for end users.

Our client look for someone who has a good customer oriented view and who has the flexibility and willingness to develop a good base understanding (not directly linked to statistics) of the different supported areas (analytical chemistry, process chemistry, etc). She/he must be capable to deal with very different issues coming from different areas at the same time. The person should have good communication and teaching skills.

Your profile

• Master degree in statistics, PhD in statistics is a plus
• Very good knowledge of multivariate analysis (regression analysis, PCA, PLS), multivariate statistical process control and experimental designs.
• Knowledge about the prediction of data in time series (i.e. via bootstrapping or lag-KNN) is a plus
• Proficiency with R, JMP and SAS (base, stat) is expected. Other statistical packages knowledge is an asset (SIMCA, …).
• Some background in Pharmaceutical R&D and Manufacturing.
• Experience in multidisciplinary projects.
• Fluent English is required, French is a plus.

This description matches your profile and expectations?

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