The purpose of the Biostatistics and Data Management Core for this program project is to provide acomprehensive, multi-disciplinary resource for design of clinical and basic science experiments,development of appropriate and innovative statistical methodology, statistical analysis, and summarizing theresults. The Biostatistics and Data Management Core has the following overall goals: to provide statisticalconsulting and collaboration on the design, conduct, analysis and interpretation of all program projectresearch studies and cores, and to provide, manage and maintain a high-quality research database thatsupports the research projects and cores while preserving the confidentiality of all subject data.
The specificaims are: (1) Coordinate and manage statistical activities in the program project to ensure that investigatorshave ready access to statistical consultation and support. (2) Provide statistical expertise in the design ofexperiments and studies, including research proposal development, sample size determination,randomization procedures, and plans for interim reviews and final analysis. (3) Assist with the writing ofstatistical components of manuscripts. (4) Review, in conjunction with the Clinical Translational ReviewCommittee, the integrity and statistical soundness of all studies involving human subjects. (5) Providestatistical analysis for all projects using appropriate statistical and computing methodologies, assist in theinterpretation and presentation of results. (6) Interact and collaborate with the Clinical Trials andTranslational Research Office in the development of protocols and the monitoring and reporting of clinicaldata. (7) Maintain a computing facility with up-to-date software for statistical analysis to support programproject investigators. (8) Conduct biostatistical methodology research on practical problems arising in cancerstudies. (9) Provide computer-based tools that facilitate the storage and retrieval of the data generated in theproposed research, thereby creating and maintaining a centralized relational database that provides accessto common resources and information. (10) Ensure the accuracy of the data maintained in the database bysoftware based data consistency and quality control systems. (11) Organize and maintain the database tomaximize accuracy and accessibility; while maintaining strict confidentiality. (12) Provide detaileddescriptions of the available populations and resources for current and future investigators. (13) Providehigh-quality data entry services.
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