CORE 3 - BIOSTATISTICS AND BIOINFORMATICS CORE: SUMMARY The overarching goal of the ELEVATE program project grant (PPG) is to leverage molecular abnormalities in hepatocellular carcinoma (HCC) to develop novel and effective therapeutic combinations, especially targeting NASH-HCC. The overarching goal of Core 3 (the Biostatistics and Bioinformatics Core [BBC]) is to promote excellence in the basic science research and pre-clinical translational research proposed in the PPG application by providing dedicated and outstanding consultation and collaborative support and expertise in biostatistics, bioinformatics, and research data management for ELEVATE Projects 1-4, Core 1 (Administrative Core), and Core 2 (Mouse Models and Pathological Analysis Core), and as needed. The biostatistics component will provide expertise in experimental design, statistical analysis, and inference for all experimental studies across all four Projects, the Administrative Core, and Core 2. Support for biostatistical assistance is proposed to address issues of 1) experimental design; 2) data analysis and the interpretation and reporting of results; 3) quality assurance of data; and 4) the application of proper statistical methodology. Biostatisticians will provide support in the statistical aspects of study design, including adequate sample size requirements and appropriate design layouts for making valid inferences for specified research hypotheses; collaborate with Project Leaders in data analysis and data summarization; consult with investigators and other Core facilities on statistical issues; and assist investigators in the preparation of abstracts, presentations, and manuscripts. The biostatistics team draws its strength from the biostatistics faculty and staff with many years of collaboration with the ELEVATE investigators. The bioinformatics component will provide support in genomic data analysis. The bioinformatics personnel comprise bioinformaticians with expertise in managing, analyzing, and interpreting large-scale genomic studies, including the analysis of high-throughput sequencing datasets proposed in the PPG. The Bioinformatics team has a record of collaboration with ELEVATE investigators. In supporting the Administrative Core and the PPG overall, the BBC will provide support for integrating clinical and laboratory data to enhance data sharing among ELEVATE investigators and to ensure reproducibility and timely dissemination of high- quality data.