Netherlands
I am a non-clinical statistician who has been supporting manufacturing and R&D processes.
Giving statistical support to the Manufacturing Division (MMD). My main responsibilities are industrial process optimizations, stability studies, method validations and transfers.
Giving statistical support to GSK in clinical assay development.
Giving statistical support to vaccine research and development in the animal health industry. My main responsibilities were animal safety, efficacy and post market authorization studies, method and process optimization, method development and transfers, MRT specifications, authority RtQ discussions and various industrial and other minor statistics related issues.
Giving overall statistical support to method development and comparability studies for biosimilar development in the pre-clinical phase for three years.