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CCTS Biostatistics, Epidemiology, and Research Design


Collaboration with a biostatistician typically provides higher quality and reliable results that stand up to critical peer review. Issues that are not obvious to investigators are identified and addressed and all efforts are made to ensure the investigator’s aims are met through statistically rigorous methods.

Biostatisticians vary in their area of expertise. Some focus on clinical trial design, analysis and oversight, others focus on observational study methods, laboratory experimental design and analysis, or high dimensional studies (microarray, sequence data, etc.). Specific biostatistical expertise is also important to peer reviewers.





    • Clinical Trial Design ( Service )

      Biostatisticians work with principal investigators on clinical trials to investigate improved methods of treatment, prevention, detection, and diagnosis.
      Areas of expertise in clinical trials include:
      • Bayesian designs
      • Adaptive designs
      • Interim analyses and monitoring
      • Hypothesis testing strategies for multiple endpoints or groups
      • Development of study design and decision rules
      • Choice of outcome measures
      • Sample size and power calculations
      • Development of case report / data collection forms
      • Re-estimation of sample size
      • Repeated measures designs including cross-over and semi-cross-over

    • Clinical Trials and the Analysis of Genomics Data Workshops ( Support service )

      We offer workshops on clinical trials and the analysis of genomics data. We also provide lectures and teach courses in core areas in biostatistics, epidemiology and biomedical informatics including reproducible research.

    • Data Analysis ( Data analysis service )

      Data Analysis - Our group is experienced in the analysis of a wide variety of data including preclinical studies and biomarker discovery (‘omics) approaches, complex longitudinal and cross sectional studies, registry data, data from electronic medical records, and clinical trials.

    • Grant Preparation ( Support service )

      Grant Preparation We are experienced in both intramural and extramural grant submissions including NIH, DOD, AHRQ, PCORI, NSF and foundation grants and will work with investigators starting from the genesis and formulation of research hypotheses, to the design phase and sample size calculations, and finally writing a statistical analysis plan. This also includes selecting appropriate study populations and control groups, measures of exposures and outcomes, and datasets for secondary data analysis.

    • Hypothesis, Study Design and Statistical Analysis Walk-in Clinic ( Support service )

      Walk-In Clinic Available 1:00 – 3:00 pm on Monday and Thursday in Prior Hall, Suite 260. Intended for short (30 min) discussions about your hypothesis, study design and statistical analysis.

    • Navigator Model (embed biostatisticians) ( Support service )

      To bolster team science, we embed biostatisticians within a research program and become involved with the research from its genesis. Navigators are intimately familiar with the clinical, biological and statistical issues related to the biomedical domain and naturally serve as point persons for establishing collaborations.

    • Planning Multi-PI Level Grants and Data Coordinating Centers Multidisciplinary Collaborations ( Service )

      Multidisciplinary Collaborations BERD develops methodology in concert with our clinical, basic, and population level collaborations to promote multidisciplinary team science. We have expertise which spans causal inference, genetic epidemiology, statistical genomics, metabolomics, reproductive and pediatric epidemiology, survival analysis, missing values, and clinical trials. Interested faculty members should enquire with us about planning multi-PI level grants and data coordinating centers

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    Last updated: 2020-09-18T10:59:52.421-04:00

    Copyright © 2016 by the President and Fellows of Harvard College
    The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016