Biostatistics Core Facility
The Biostatistics Unit provides consultative and collaborative support to VCC investigators in the general areas of study design, data collection and quality control, data processing, data management, statistical methods development, statistical analysis and interpretation, and manuscript preparation.
Biostatistical Design & Analysis
- Ensure that study objectives are clearly stated along with treatment conditions, subject inclusion and exclusion criteria, definition of study outcomes, and subject withdrawal criteria.
- Ensure study feasibility and appropriateness of study designs including development of non-standard study designs for Phase 1, 2 and 3 trials.
- Determine populations to be studied, unit of analysis, sample size and power calculations, randomization methods as well as specification of mathematical and statistical models to address study objectives.
- Develop and implement cost effective statistical analysis plans, and present the results of statistical analyses.
- Interpret results and co-author manuscripts and abstracts for professional presentations.
- Conduct statistical methods and software development efforts, and adapt existing statistical methods and software in order to optimize data analysis efforts.
- Support the scientific reviews of research protocols reviewed by the VCC Protocol Review Committee.
- Serve on the Clinical Research Oversight Committee to assist in the periodic review of all clinical studies.
Database Design & Data Management
- Design, develop and validate data collection instruments using self-coding techniques to minimize missing or inconsistent data.
- Ensure that data collection and quality control issues such as data entry verification, data editing and screening are included as part of study procedures or the manual of operations for larger trials.
- Design data collection and quality control studies to monitor study processes.
- Ensure documentation of data file structures, changes to data file structures and data file content, backup of databases, and statistical analysis output files along with statistical analysis code.
- Ensure database portability across database and statistical software packages.
- Assist with both planned and unplanned interim statistical progress reports.
- Provide integrated hardware and software support, and data management support.
Last modified November 21 2013 02:47 PM