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 is currently working on models to estimate false positive levels in cardio-oncology safety reporting. 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 and American Society for Clinical Oncology meetings reports regularly on trends in FDA policy and cancer treatment. He has numerous publications in the medical and statistical journals and presentations at statistical meetings. His book, Data and Safety Monitoring in Clinical Trials, Second Edition, Chapman and Hall, 2017 is considered the definitive guide to safety review in industry – sponsored clinical trials.
Jay now works as a consultant or data monitoring committee member for several pharmaceutical, biotech and medical device firms. He recently served as principal biostatistical consultant for the first approved biosimilar to the popular cancer drug trastuzumab. He is now at work on a biosimilar to bevacizumab. Serving as Senior Associate in Biostatistics at Johns Hopkins Bloomberg School of Public Health, Baltimore, he teaches in several graduate courses and is a regular attendee at journal clubs and seminars and serves as a career counselor and placement advisor to master’s students. He volunteers weekly as a newsreader for the blind on Dial In radio.
Jay’s second career is that of a futurist. He has written articles and been an invited speaker on the future of the pharmaceutical industry, scenarios for the coming osteoporosis epidemic, the future of air travel, volunteerism, health insurance, Maryland counties and podiatry practice. He often combines standup comedy with his futurist talks.