11:00 AM - 04:00 PM
DAY 1

Session 1: Why Statistics
• Do we really need statistical tests?
• Sample vs. Population
• I’m a statistician not a magician! What statistics can and can’t do
• Descriptive statistics and measures of variability


Session 2: The many ways of interpretation
• Confidence intervals
• p-values
• effect sizes
• Clinical vs. meaningful significance


Session 3: Common Statistical Tests
• Comparative tests
• Regression analysis
• Non-parametric techniques


Session 4: Bayesian Logic
• A different way of thinking
• Bayesian methods and statistical significance
• Bayesian applications to diagnostics testing
• Bayesian applications to genetics

11:00 AM - 04:00 PM
DAY 2

Session 1: Systematic Reviews and Meta-Analysis
• Why perform a systematic reviews and/or meta-analysis?
• A bit of history and reasoning for systematic reviews and/or meta analysis
• Terminology
• Steps in performing a Systematic Review
• Steps in performing a Meta-Analysis


Session 2: Study power and sample size
• Review of p-value, significance level, effect size
• Formulas, software, and other resources for computing a sample size


Session 3: Developing a Statistical Analysis Plan
• Using FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).
• An SAP template will be given to all attendees.


Session 4: Specialized topics & Other Tests
• Survival Curves and Cox Regression
• Logistic Regression
• Taking a holistic view to study design and interpretation
• Non-Parametric tests
• Test for equivalency
• Test for non-inferiority
• Question and Answer session