Project Summary – Bioinformatics and Biostatistics Core C The Biostatistics Core has been an integral part of the first Wistar/UPenn SPORE in Skin Cancer (2001-2009; 2014-2019). Core C functionality and interaction with skin cancer researchers on both campuses has remained intact throughout the last 19 years resulting in many high impact publications, reporting key advances in melanoma. To meet the changing needs of the Projects and anticipated needs of the Pilot Programs, Core C has become the Biostatistics & Bioinformatics Core. Core C key personnel will continue to play a critical role in the statistical design, statistical analysis, and dissemination of research results for all experimental and clinical studies defined within the Projects, as well as the Career Enhancement Program (CEP) and Developmental Research Programs (DRP) research activities. The members of this core include two senior biostatisticians and a bioinformatician, who have complementary expertise, extensive collaborations with SPORE investigators, knowledge of new developments in biostatistical and bioinformatics methods and their application to research proposed in the SPORE, and an extensive publication record that reflects their expertise in melanoma and other skin cancers. The biostatisticians are members of the Division of Biostatistics of the Department of Biostatistics and Epidemiology and are part of the Biostatistics Shared Resource of the Abramson Cancer Center at the University of Pennsylvania. The bioinformatician is a faculty member of the Wistar Institute. The Biostatistics and Bioinformatics Core key personnel will provide expertise and experience in five key areas. The first is to provide a robust computational and data management environment for datasets developed by the research projects and the Biospecimen and Pathology Core (Core B). The second is to provide expertise on research methodologies to design and implement rigorous laboratory studies, biomarker studies and clinical trials. The third is to provide expertise on statistical methodologies critical to each research project. These activities include plans for the data preprocessing and analysis for big data discovery studies, testing proposed statistical hypotheses as well as the development of statistical models. The fourth is to conduct evaluations of different methodologies to identify the most effective approach, developing new methods when standard methods are not appropriate, and to conduct discovery studies using archived public databases relevant to the research projects. The fifth is to provide expert interpretation of research data and collaboration with Project investigators to make scientifically and statistically appropriate statements, as well as to assist in the preparation of scientific abstracts, presentations, and manuscripts. All of the Core C key personnel have played a major role in designing the Projects in this SPORE application, and expect to play an instrumental role in the success of the next cycle.

Project Narrative – Biostatistics and Bioinformatics Core C Collaboration between the Biostatistics and Bioinformatics Core and the research investigators conducting SPORE-related studies will insure that the SPORE research studies will have strong bioinformatics infrastructure, high quality study designs and tailored statistical analysis plans that will provide a solid foundation for each study’s conclusions. This will ensure Scientific Rigor and enhance the impact of discoveries on the care of patients with melanoma and other skin cancers.