Working as part of a statistician within the Stat Unit, you will work closely with people from New Product Introduction, Manufacturing, Quality Control, and Regulatory Affairs Departments to support the introduction of new drug and ensure consistent production and release of batches.
You will provide statistical consultancy in relation with method/process transfer and validation, product homogeneity and stability, process optimization and control. You 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.
You will continuously look for improvement in the way the team operates, i.e., the quality and efficiency of the service the team offers to its clients. You will also work in a GMP environment, where you will have to comply with the company’s standard operating procedures and authorities guidelines.
In this job, you will have the opportunity to work on various business topics, applying a wide
range of statistical methods. You will collaborate with all the actors of the supply chain using
high quality standards.
Education: University level in Mathematics/statistics or Sciences with complementary degree in Statiscics.
Experience : 3 years of proven experience in statistics within research and/or industrial environment.
Fluency in French and English is desired.
Experience in pre-clinical and/or manufacturing statistics is an asset.
statistical intervals (confidence, prediction, tolerance intervals), fixed and mixed effects ANOVA models, regression analysis, statistical process control, experimental designs and sampling plans (AQL)