The use of statistics to support discovery and testing of new medicines has grown exponentially since the 1962 Kefauver-Harris Amendments. These amendments required drug sponsors to prove a product’s safety and efficacy in controlled clinical trials in order to take a product to market. The statistician’s role “to assist the process of developing medicines which will deliver benefits to patients” continues to evolve. As a biostatistician what do you need to do to be a full participant and contributor to drug development in the future?


A Ph.D. or MS in Statistics or Biostatistics, while required, is not enough. Understanding the broad public health context and working with clinical and regulatory as a full and equal partner are critical to your success and the success of your firm’s drug development. As a biostatistician you will solve problems differently from other scientists which adds important diversity to the debate. Staying abreast of parallel development in other disciplines like epidemiology, genomics, biomarker development and risk management will expand your contribution.


In experimental design you want to review multiple options. In execution both quality control and risk mitigation is essential. In analysis take into account planned and unplanned results and the strengths and weaknesses of your research and results. Is your interpretation pre-planned or data driven. And, always, when doing presentations or writing for publication keep your audience in mind.

It is generally recognized that less than 12% of compounds entering into the human phase testing will eventually make it to the marketplace. Statisticians can help reduce this attrition rate at the late change through the use of adaptive designs or at least group sequential designs. The goal of these designs would be to give Phase III trials the best chance for success or the earliest decision to terminate if the trials are not likely to meet their objectives.


Support the public desire for more transparency in clinical research and clinical reporting. There is a perceived need for more public control over the search for valuable medicines due to a loss of public confidence in the clinical research process and the pharmaceutical industry. Fostering partnerships with academia, your peers in other pharmaceutical organizations and government will help solve the complex problems you face through sharing resources and knowledge, and increase credibility through peer review. Working together is more effective than working in isolation.

Want to know more about a career in biostatistics? Contact Nihar Parikh, Smith Hanley Associates Executive Recruiter, at


Source article:

Leave a Reply

Your email address will not be published.