PROJECT SUMMARY The Biostatistics Core will provide the timely and high-quality statistical support necessary for the success of the Program Project. The Biostatistical support will center on three specific aims: 1) provide support for the design, analysis and proper inference from the laboratory and patient sample studies conducted in the Projects, 2) apply state-of-the-art statistical tools to gain additional insights into data created in the Projects and 3) provide support for combining data from multiple sources. The general analysis principles include methods to validate assumptions; improve precision by removing known sources of variation, such as experiment to experiment variability; control for multiple hypothesis testing; and validate models. The data and programming support will provide expertise in merging data from multiple sources and archiving data to allow the results of data analyses to be preserved and reproduced. Biostatistics support is critical for the success of the Program Project. The Biostatistics Core provides easy and guaranteed access for investigators and also allows the biostatisticians to specialize in the Project areas regarding content knowledge and appropriate statistical methodology. A dedicated Core provides timely and high-quality biostatistical services as its focus.