John Schoenfelder

Vice President, Biometrics

John Robert Schoenfelder, Ph.D., recently joined Hurley Consulting as Vice President of Biometrics. He has twenty-five years experience in the pharmaceutical industry. Dr. Schoenfelder is responsible for the design and conduct of statistical analyses and data management activities at Hurley Consulting. He assures that timely and high quality analyses are conducted, utilizing appropriate statistical techniques, in accordance with the protocol, the statistical analysis plan, and health authority guidelines. In addition, he is responsible for the statistical interpretation of data analyses, and in conjunction with the person responsible for the scientific and/or clinical interpretation of the date, he determines the final data interpretation. He is responsible for providing the results of statistical analyses to the Vice President, Scientific Affairs, and Vice President, Regulatory Affairs, and for supporting the creation of clinical reports and summary documents. Dr. Schoenfelder supervises all employees in the Statistics, Programming, and Data Management group, and coordinates work within the group and with other groups at Hurley Consulting.

Before joining Hurley Consulting, Dr. Schoenfelder was employed by Pfizer or one of its acquired companies for sixteen years. From 1990 to 2003 he held positions as director of statistics and biometric activities at Pharmacia Inc. in the United States, Pharmacia and Upjohn AB in Sweden, and Pharmacia Ltd. in the United Kingdom. From 2003 through 2005, he was Senior Director, Clinical Statistics Therapeutic Area Section Head, at Pfizer Ltd. in Sandwich, Kent, UK, where he was responsible for clinical statistical support for the metabolic, allergy and respiratory; anti-infectives and anti-virals; and opthamology therapeutic areas.

Prior to his work at Pharmacia, he was Assistant and then Associate Director in the Biostatistics Department at Glaxo, Inc. in 1988 and 1989. From 1980 to 1987, he provided statistical support as senior statistician, primarily to the respiratory and anesthesiology sections of the medical division, in the areas of protocol development, data analysis, and statistical report, involving Phase I, II, and III clinical trials and NDA submissions at Burroughs Wellcome, Co.

Dr. Schoenfelder was an adjunct assistant professor in the Department of Biostatistics, University of North Carolina School of Public Health from 1982 to 1990, and was President of the North Carolina Chapter of the American Statistical Association in 1989-90.

Dr. Schoenfelder holds doctoral and master's degrees in statistics from the University of North Carolina at Chapel Hill, and a bachelor's degree in mathematics and physics from Cornell College. He is a member of the American Statistical Association; Biometric Society, Eastern North American Region; Institute of Mathematical Statistics; International Society of Clinical Biostatistics; Drug Information Association; and Statisticians in the Pharmaceutical Industry. He has approximately fifty publications and presentations in his name and has coauthored two books, Presentation of Clinical Data and Data Collection Forms in Clinical Trials.