Mayo Clinic's Biostatistics Core provides services for each stage of your research study.
Concept and protocol design
The best time to start collaborating with a biostatistician to discuss the concept and study design is before data are collected. Biostatisticians help investigators make decisions in concept and protocol design. For example, the biostatistician and statistical programmer may:
- Formulate testable hypotheses or refine aims that can be addressed through data.
- Propose a study design including identification of study designs best suited to the aims and hypothesis.
- Discuss the number of subjects or samples needed to appropriately power the study to detect relevant effects or associations.
- Develop and write a statistical analysis plan by identifying appropriate methodology.
- Write statistical sections for protocols and collaborate on protocol development before submission to the institutional review board (IRB) or committee review.
- Write statistical sections of grant proposals and provide feedback throughout the writing process.
Database and data collection
Biostatisticians and statistical programmers are well suited to collaborate on database builds, data collection and monitoring of prospective study data accrual. They may:
- Design and build electronic data capture for clinical trials or observational studies using REDCap, Medidata Rave, the scientific data management system or other systems.
- Extract data from the electronic health record while providing full compliance with privacy regulations, state law and Mayo Clinic policy; staff have extensive knowledge of existing data sources, the data elements the sources contain, and the methods used to extract or retrieve data.
- Extract or obtain data from institutional databases including the Rochester Epidemiology Project and other sources.
- Integrate data from diverse sources into a combined data set or database.
- Maintain and monitor ongoing databases.
- Develop data dictionaries.
- Create statistical programs for data monitoring including issuing queries for missing data or potentially incorrect data entry, or summarizing data for data safety and monitoring board meetings.
- Cleaning and preparing data for analysis.
Analysis and write-up
The biostatistical team has the expertise to develop and plan statistical analyses, write statistical code to analyze data, and collaborate in dissemination of results. Core staff may:
- Develop a statistical analysis plan and select appropriate methods based on the study aims or hypotheses.
- Write and document code using R, SAS or other statistical software.
- Generate tables, figures and summaries of results for publication or presentation.
- Co-author manuscripts including drafting a statistical methods section and critically revising the entire manuscript with special consideration on interpretation of statistical results.
- Respond to reviewers' comments on coauthored manuscripts.