Biostatistics/Data Management

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PROJECT SUMMARY (See instructions): The Biostatistics and Data Management Core will provide the statistical, systems and data management support for research conducted within the scope of SPOTRIAS projects. This will include collaboration and consultation on the statistical aspects of study design and planning, electronic data capture (EDC) system development and maintenance, data quality control and study monitoring as well as data analysis and interpretation. The Core will ensure adherence to the highest standards of good statistical and data management practice. The specific aims of this Core are: 1. To provide statistical and computational expertise for the design, planning, conduct, analysis, and reporting of laboratory experiments, imaging studies, observational studies, and clinical trials associated with the Partners based SPOTRIAS Projects. 2. To provide ready access to statistical and computational expertise to the entire group of SPOTRIAS investigators through "open door" consultation. 3. To advise and support SPOTRIAS investigators in the areas of electronic case report forms (eCRFs) design, data collection, electronic data capture and data management system (ECD&DM) design and development, and data quality control. 4. To collaborate with Biostatisticians on provision of reports to study principal investigators, medical monitor, and the Data Safety and Monitoring Board (DSMB).