Principal Non - Clinical Biostatistician

You will be responsible for contributing to the reliability, scientific quality, and optimization of project support throughout the entire process from target identification to process development. This will involve performing statistical analyses of data generated in the laboratories using R and potentially other programming languages to generate statistical reports. Additionally, you will play a key role in the development and maintenance of statistical end-user tools. Your expertise will be utilized in representing statistics within various scientific or technology working groups and cross-functional initiatives. To excel in this role, you should possess a strong background in non-clinical statistics as applied to biopharmaceutical development. Your proven experience in industrial statistics, including descriptive and inferential statistics, statistical process control, design of experiments, multivariate data analysis (such as PCA, PLS, and related methods), and statistical modeling and simulation will be crucial. A sound understanding of statistical concepts and techniques, such as predictive modeling and repeated measure ANOVA, is essential. Additionally, familiarity with pharmaceutical research and development, particularly in in-vitro testing, is desirable. Knowledge of CMC regulatory guidelines from organizations such as EMA, FDA, and ICH Quality, as well as QbD principles, will be valuable in this role. Your ability to prepare statistical analyses for regulatory dossiers and ensure compliance with relevant guidelines will be pivotal to the success of the projects you are involved in.,