Statisticians in the Pharmaceutical Industry: The 21st Century

Pharmaceutical statisticians have come a long way during the past 50 years in supporting product discovery, development, manufacturing, and commercialization. Statisticians are either equal partners or are consultants in all areas of pharmaceutical research and development. While statistics is enjoying a greater role in the current environment, our industry is facing unprecedented challenges. The number of approved new molecular entities has decreased in recent years. The public is expecting medicines that are more effective and have fewer side effects. Many of our customers are demanding greater data disclosure, greater transparency, and higher standards of evidence. At the same time, public trust in our industry and regulators is at its lowest point since the 1970s. To face this unfavorable external environment and to take advantage of the rapidly emerging information to drive innovations, many companies have joined forces to form collaborative partnerships. The collaborations cover not only scientific pursuits, but also operational efficiency. In this article, we discuss the changing landscape of the 21st century. More importantly, we discuss what statisticians should do to rise to the challenges and take advantage of the opportunities in an environment where “openness” is a major consideration that will govern many public and private decisions.