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Robert W. Makuch, Ph.D (born July 15, 1950) is an American mathematician, academic, and renowned biostatistician. Dr. Makuch currently serves as full tenured professor in the Department of Biostatistics at the Yale School of Public Health and Director of the Regulatory Affairs Track.

Dr. Makuch is well recognized for his expert statistical and regulatory consultations to the pharmaceutical industry and to national and international governmental regulatory agencies. He is an Elected Fellow of the American Statistical Association, cited for his expert statistical consultation to government and the pharmaceutical industry and his innovative contributions to the methodological design and analysis of clinical trials. He is a Prolific Author and Frequent Conference Speaker.

'''Dr. Makuch worked at the National Cancer Institute (NCI) and the World Health Organization’s International Agency for Research on Cancer early in his career. He had worked at the National Cancer Research Center in Tokyo, Japan and was heavily involved in HIV research from the mid 80's through the early-mid 90's. He participated on the data monitoring committee for the original AZT vs. placebo randomized clinical trial in AIDS patients, and served on numerous committees for the NCI and the National Institute of Allergy and Infectious Diseases. Dr. Makuch had worked closely with the Food and Drug Administration (FDA), developing and implementing more than 200 HIV studies. He also served as a Special Government Employee (SGE) to the FDA. He returned to Yale in 1986, and has worked extensively on methodologic issues in clinical trials and large population-based studies since. Another area of interest involves detection of rare adverse drug events, especially in the post-marketing environment. These areas of methodologic research evolved as a result of his continued interest (since the mid 1980s) in regulatory affairs science. In addition, Makuch developed a regulatory affairs track at YSPH for graduate and post-doctoral level students, and over the past 10 years has been the leader of more than 25 training programs for senior delegations of the Chinese Food and Drug Administration. His areas of medical application include cancer, HIV, arthritis, and cardiovascular disease. In 2003, Makuch received the American Statistical Association Fellow Award for his numerous contributions to the field. In 2008, Makuch received a Distinguished Alumni Award from the University of Connecticut. In 2012, Makuch was nominated to serve on the University of Connecticut Dean's Advisory Board for the College of Liberal Arts and Sciences. Dr. Makuch has been a decades-long member of Phi Beta Kappa.'''

Dr. Makuch holds MPhil and Ph.D. degree from Yale University.