Tom Vidmar
Statistician at BioSTAT Consultants
Senior Director, Nonclinical Statistics, Pfizer (2003-2008)
Abstract:
Laboratory fraud in the U.S. spawned the creation of Good Laboratory Practices (GLP’s) in 1979. This regulation controls the conduct of drug safety assessment in the pharmaceutical industry. The focus of this talk will be on the statistical analysis of 2-year carcinogenicity studies. These studies use 200-280 rats/mice and the cost can be upwards of 2.5 million dollars. Like the name suggests these studies count tumors that impact survival. Several discrete data statistical methods that you are familiar with are used as are several methods that you probably have not encountered. As the statistician charged with the analysis of this data, this is an expensive and important study you want to do properly.
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All statistics graduate students are expected to attend.