08: A Brief History of Nonclinical Statistics Departments within the Pharmaceutical Industry

Music City Center 

For more than a half century, the US pharmaceutical industry has employed statisticians to support the development and marketing of therapeutically important compounds. Although the earliest statisticians in the industry date back to the 1950s, separate administratively organized statistics departments began to be formally established in the mid to late 1970s. These early groups were mainly clinical statistics departments, supporting human dug trials, that formed because of the passage in 1962 of the Kefauver–Harris Amendment to the 1938 Food, Drug and Cosmetic Act. Hiring of nonclinical statisticians to the industry can be traced back to the publication of the 21 CFR Part 58 - Good laboratory practice for nonclinical laboratory studies regulation in 1978. This prompted many companies to hire statisticians to support drug safety and toxicology studies and marked the impetus for the creation of nonclinical statistics groups with a distinct administrative identity. These groups went on to expand the scope of their statistical services to early development and CMC studies. This presentation will examine the development and expansion of nonclinical statistics departments in the US pha

nonclinical statistics


pharmaceutical industry


history of statistics 

History of Statistics Interest Group