Biostatistical Consultation

Overview

The Biostatistics, Epidemiology and Research Design (BERD) Core was designed to support a large number of trans-institutional projects encompassing a broad spectrum of disciplines. Its principal objective is to provide biostatistical resources for the design and conduct of studies within the Clinical and Translational Science Center. Through the integration of the diverse statistical resources already available across the partnering institutions, the specific aims of this core are to:

  • Provide a scientific and administrative structure that supports investigators from diverse backgrounds.
  • Provide high-quality consultation in research design and biostatistical analysis
  • Train and mentor laboratory and clinical investigators in the quantitative aspects of research
  • Support methodological research for development of novel research design, advancement of efficient analysis methods, and enhancement of statistical software

Services Offered

1. Study Design and Proposal Development

  • Formulate wording of testable hypotheses and associated primary aims
  • Suggest a optimal study design
  • Help evaluate related published literature on planned measures for adequate evidence of reliability and validity
  • Determine the needed sample size or estimated power and write this up
  • Write the statistical analysis plan for the protocol
  • Respond to relevant parts of a critique by reviewers of the protocol

2. Implementation and Study Conduct

  • Review proposed data collection instruments and other measures for reliability, validity, and suitability for the planned data analysis
  • Establish coding rules with data entry staff, such as handling of missing data and invalid responses on questionnaires
  • Respond to questions about methodology, including protocol irregularities and changes.

3. Data Management

  • We connect our collaborators with Ms. Jessie Lee of the CTSC Informatics Core Group who can help with identifying and setting up appropriate systems for research data management.

4. Data Analysis

  • Audit data for completeness and validity
  • Plan, direct, interpret, and report any interim analysis, and advise on changes
  • Plan, direct, interpret, and report the final data analysis
  • Present and explain analytic results to co-investigators and project team

5. Presentation/Publication

  • Design and direct preparation of tables and publication graphs
  • Collaborate in writing papers, abstracts, presentations
  • Review data accuracy and interpretation of inferential statistics in all reports of study methods and results
  • Respond to journal referees with written comments and/or additional analyses or data

6. Other Services

  • Provide tutorial paper on various methodologies for self-reading
  • Write 'letter of support' for grants
  • Identify researchers from participating institutions for collaborations on projects and pilot grants

Clinical & Translational Science Center 1300 York Ave., Box 149 New York, NY 10065