Professional statisticians have taken 30-50 graduate hours of coursework in order to understand the theory and practice of statistics. And it is a language and thought process that does not come easily to most normal folks. Therefore statistics presents none-too-simple challenges for non-statisticians. Yet the concepts and practice of statistics represent an essential building block for deciding if a prescription medication or medical device is effective and safe, as required by governmental regulations throughout the world.

Tasks in which a professional statistician ought to be involved in the clinical process include the following: developing clinical plans, designing studies, protocol review and writing, writing statistical analysis plans, the analysis and interpretation of data, writing and reviewing the clinical study report, planning an NDA/BLA/MAA, and negotiating with regulatory bodies. Thus it is imperative that enhanced communications be developed in order for non-statisticians and statisticians to work together to create and implement high quality science to improve patients' lives.