Biostatistics in Clinical Research
This training program provides a comprehensive introduction to biostatistics in the context of clinical research. Across ten modules, it covers the essential statistical concepts, methods, and applications that form the foundation of clinical trial design, analysis, and reporting. Learners begin with the fundamentals of clinical research (role of the statistician, protocols, SAPs, and CSRs) and then progress through key statistical principles such as measures of central tendency, dispersion, and hypothesis testing.
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Course Overview
Course Curriculum
1 Subject
Biostatistics
69 Learning Materials
SOP'S
1. Introductory PPT
1.1 Understanding Roles and Responsibilities in Clinical Research
1.2 The Role of Statistician
1.3 Protocol
1.4 Sample Size
1.5 Data Handling
1.6 Statistical Analysis Plan
1.7 Clinical Study Report
2. Measure of Central Tendency
2.1 Mean
2.2 Median
2.3 Mode
2.4 Quartile
3. Measure of Dispersion
3.1 Variance & Standard deviation
3.2 Range
4. Study Designs
4.1 Types of Study
4.2 Prospective & Retrospective Study
4.3 Cohort study
4.4 Cross over study
4.5 Parallel Study
5. Randomization
5.1 Simple Randomization
5.2 Block Randomization
5.3 Stratified Randomization
5.4 Cluster Randomization
5.5 Randomization in SAS Programming
6. Testing of Hypothesis
6.1 Qualitative & Quantitative Data
6.2 Type I & Type II Error
6.3 Confidence Interval
6.4 P-Value
6.5 Power
7. Statistical Tests
7.1 How to check Normality?
7.2 Identifing Parametric and Non parametric test
7.3 T-Test
7.4 Two Sample t-test
7.5 ANOVA
7.6 ANCOVA
7.7 MANOVA
7.8 RMANOVA
7.9 F-Test
7.10 Z-Test
7.11 Kruskal Wallis Test
7.12 Wilcoxon Signed Rank Test
7.13 Wilcoxon Rank Sum Test
7.14 Chi-square Test
7.15 Fishers Test
8. Correlation and Regression
8.1 Correlation
8.2 Regression Analysis
8.3 Logistic Regression
8.4 Hazard Ratio
8.5 Odds Ratio
8.6 Relative Ratio
9. Graphical Representation
9.1 Bar Diagram
9.2 Histogram
9.3 Pie Diagram
9.4 Cumulative Curve
9.5 Fitting Index Curve
9.6 Error Bar
9.7 Probability Plot
9.8 Sankey Plot
9.9 Forest Plot
9.10 Funnel Plot
9.11 Mean Plot
9.12 SPAGHETTI Plot
10. Required analysis according to data
10.1 KM Curve
10.2 Log Rank Test
10.3 Cox Proportional Hazard Model
10.4 Interim Analysis
10.5 Meta Analysis
10.6 Propensity Score
10.7 Population Set
10.8 PK/PD & BA/BE Analysis
Course Instructor
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