The primary objective of the core is to ensure that studies are well designed, correctly analyzed, clearly presented, and correctly interpreted. The Core offers a variety of services.

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Providing consultation during study design, endpoints and statistical model.

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Providing statistical and methodological support of all study protocols.

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Providing statistical and methodological support for grant applications submitted

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Providing consultation on data collection and management for various studies and models.

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Collaborating in the analysis of data for manuscripts, poster or oral presentations and grant submission.

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Providing statistical and other quantitative training for members of the Ragon Institute.

Study Design

  • Design a valid study
    • Selection of appropriate study design
    • Appropriate sampling & randomization techniques
    • Sample size calculation & power justification
  • Study monitoring
    • Interim analysis (monitor safety, efficacy/lack of efficacy)

Protocol Development

  • Protocol development for IRB review
    • IRB (PHRC, BREC) protocol submission and amendment

Grant Application

  • All grants and fellowships
    • Hypotheses formulation and endpoint identification
    • Sample size calculation and power justification
    • Statistical analyses plan
  • Research program/center grants (e.g., U19/P01/U01/HIVRAD)
    • Prepare biostat core or admin/biostat core
  • Research grants (R01, R03, R21)
    • Prepare statistical analysis plan
  • Training grants (e.g., K01/K08/K23/K25)
    • Serve as a scientific advisor (statistics mentor)
  • Research Training & Fellowships ( T & F Series)
    • Serve as a scientific advisor

Data Management

  • Integrity checks to ensure accuracy
  • Data storage & archiving

Data Analysis

  • Advice on the choice of appropriate method (luck of broadly neutralizing analytic tools)
    • Model assumptions
    • Model fitness capability
    • Model prediction capability
  • Analyze data (over the counter analytic tools do not cure all problems)
    • Modify the methodological deficiencies of the exiting methods
    • Develop new methods

Statistical Education

  • Statistical interpretation of analyses results
  • Statistical education (informal and formal trainings)

Service Charges

Co-investigator status on a grant application is expected for grants of R21/R03 size or bigger. The percent effort of the Core personnel is determined by the statistical needs of the grants. All grant applications must be reviewed and approved by the Biostatistics Core before submission.

Co-authorship on a manuscript is expected for non-trivial consultations. That is, publications resulting from collaboration with the Biostatistics Core merit co-authorship. The order of authorship is decided based on the amount of work done. Considerations of co-authorship should be based on the intellectual and research contributions of the collaborators and should not be viewed as a substitute for payment. For publications which involve trivial consultations with the Biostatistics Core, acknowledgement of the Core is required.

Submission Requests

Requests for biostatistics consultations should be made to Dr. Musie Ghebremichael.Requests will be handled based on order received, with priority given to grant proposals and abstract preparation.Advance notice is required for consultation in grant preparation. This will provide the biostatisticians sufficient time to fully understand the science of the project and to prepare the statistical section of the grant.