Biostatistics is central to the pharmaceutical drug development. Because of this central role biostatistics is strictly supervised and guided by regulatory authorities. Key steps in the non-clinical and clinical studies are definition of study design, estimation of sample size, randomisation, statistical analysis plan, subject classification and finally statistical analysis and reporting of the data.

Biostatisticians are key players in all these steps. At Orion, statistical methods are applied in non-clinical and clinical studies as well as in pharmaceutical applications.