1. Overall agenda Part 1 and 2  Part 1: Basic statistical concepts and descriptive statistics summarizing and visualising data describing data -measures of location and variation -exploring data -types of data population and sample  Part 2: Statistical Distributions concepts important distributions: -Normal distribution and related -other important continuous distributions (life-time and survival distributions) -discrete distributions (binomial, Poisson, count data) 1| Introduction to Biostatistics | Ekkehard Glimm | 9/10 December 2013 | Part 1

2. Overall agenda Part 3 and 4  Part 3: Estimation and confidence intervals point estimates interval estimates point and interval estimates for various types of data prediction intervals  Part 4: Hypothesis testing Concept important statistical tests: -t-tests (one/paired sample, two sample with and without equal variances) -F-tests and ANOVA -testing parameters in more general models -testing hypotheses about count and binomial data 2| Introduction to Biostatistics | Ekkehard Glimm | 9/10 December 2013 | Part 1

3. Overall agenda Part 5 and 6  Part 5: Regression and correlation method of least squares and simple linear regression Multiple linear regression correlation extensions: ANOVA as regression; logistic, Poisson and non-linear regression  Part 6: design of experiments and sample size calculations types of experiments: clinical trials, observational studies, other planned experiments (parallel group designs and cross-over designs, factorial experiments) principles of experimentation: blinding, randomization, stratification operating characteristics and sample size assessment 3| Introduction to Biostatistics | Ekkehard Glimm | 9/10 December 2013 | Part 1

4. Overall agenda Part 7 and 8  Part 7: time-to-event analysis why this is special and important: survival times and censoring Kaplan-Meier curve hazard ratio the log-rank test extensions: Cox regression  Part 8: Statistics in clinical trials phases of Clinical Development: -pre-clinical research and transition Preclinical-Clinical -clinical Development Phase I -clinical development: Phases II-IV describing statistical methods and reporting statistical results 4| Introduction to Biostatistics | Ekkehard Glimm | 9/10 December 2013 | Part 1