Jay received his
Ph.D. in Biostatistics
from Johns Hopkins in 1971. Jays first positions after graduation were at the National Center for Health Statistics in Rockville, MD and the Howard University College of Medicine in Washington, DC. In 1976 he moved to Houston to work as a biostatistician on cancer clinical trials at the University of Texas MD Anderson Cancer Center
In 1983 he formed Applied Logic Associates, a contract research organization, in Houston. ALA provided data management, biostatistical and regulatory services on clinical trials for pharmaceutical, biotechnology and medical device firms. About 60% of services were delivered to emerging biotech firms working in oncology. However firms working in internal medicine and ophthalmology benefited through ALA's transfer of sophisticated statistical methods originally developed for use in cancer research. Under his leadership ALA participated in the approval of many critical care products in oncology, wound healing, epilepsy, cardiovascular disease and ophthalmology. At the time that ALA was sold to Westat, Inc. Rockville, MD in 2001 there were 50 ALA employees in Houston. Jay and his wife, Linda, moved to Chevy Chase, MD in 2003.
During the past 40 years he has developed methods for design and analysis of clinical trials with planned interim analyses and sample size re-estimation. He organized and chaired the first data monitoring committee in the pharmaceutical industry and helped FDA draft a guidance document on data monitoring committees. Jay is a regular attendee at FDA Advisory Committee meetings and reports regularly on trends in FDA policy. He has numerous publications in the medical and statistical journals and presentations at professional meetings. His book Data and Safety Monitoring Committees in Clinical Trials was published by Chapman and Hall/CRC in 2009.
Jay now works as a consultant or data monitoring committee member for several pharmaceutical, biotech and medical device firms. Serving as Senior Associate in Biostatistics, with a joint appointment in the Center for Clinical Trials, at Johns Hopkins Bloomberg School of Public Health, Baltimore, he teaches in several graduate courses, works on various research projects and coordinates activities for the biostatistics master’s degree program. He is also a member of the faculty of statistics.com and is the principal manuscript reviewer for Chapman and Hall/CRC books on statistics and clinical trials. Jay volunteers weekly as a news reader for the blind at Metropolitan Washington Ear.
Jay’s second career is that of a futurist. He has written articles on the future of the pharmaceutical industry, scenarios for the coming osteoporosis epidemic, the future of air travel, employment, primary care, global drug safety and health insurance. He is the editor of the Future Active column in the World Future Society magazine The Futurist and a coordinator of the World Future Society’s Washington DC chapter.