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Jay received his
Ph.D. in Biostatistics
from Johns Hopkins in 1971.
Jay's 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 and the Southwest
Oncology Group.
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 developed for in cancer research. At the time that ALA was sold to Westat, Inc. Rockville, MD in 2001 there
were 50 ALA employees in Houston. Under his leadership ALA was able to
participate in the approval of many critical care products in oncology, wound healing, epilepsy, cardiovascular disease and ophthalmology. Jay and his wife, Linda,
moved to Chevy Chase, MD in 2003.
During the past 30 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 and pharmaceutical company presentations. He has numerous publications in the medical and statistical journals and has made numerous
presentations at statistical meetings. He is currently writing a book on safety monitoring in clinical trials to be published by Chapman & Hall/CRC in 2008.
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 at Johns Hopkins Bloomberg School of Public Health, Baltimore, he teaches in several graduate courses and works on various research projects.
He volunteers weekly as a news reader for the blind and as a host at the Newseum, -- the museum of news -- in Washington, DC. 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 and
volunteerism. He serves as Senior Associate at the Institute for Alternative Futures, Alexandria, VA where he works with staff on future scenarios in areas such as
pharmaceutical R&D and education. He is also Managing Editor and frequent contributor to the newsletter Future Takes.
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