Functions R&D


What is Biostatistics?
Biostatistics is a specialization in statistics that focuses on application of statistical methods to studies within the realm of biology. In the context of pharma, biostatistics is a function which owns the statistical work associated with clinical trail design and analyses.

Specifically, biostatisticians in pharma can be part of clinical development teams and advise on things like proper sample sizes to ensure power, the types of statistical analyses which might be appropriate for the endpoints of interest, potential issues which may make statistical interpretation difficult and how to avoid them, etc. They help ensure that the clinical trials run by pharma and the associated statistical analysis plans are in line with broader statistical good practices.

Once data are collected, biostatistics also owns the actual execution of analyses per the statistical analysis plan. Biostatistics in pharma is often also charged with owning the post-hoc analysis work for presentation at congresses or publication as well as for potential uses for regulatory of health technology assessment purposes.