PharmaSchool: Statistics for Non-Statisticians

Please contact Jo Burmester at to find out more about in-house courses and discuss your specific needs.

Course Code: CTM002

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Duration: 1 or 2 Days


Statistics are widely used in clinical trials from the design stage and sample sizing through to the analysis and reporting. This course provides an easy to understand explanation of the various statistical terms you will come across and enables you to communicate effectively with statisticians.

Who is it suitable for?

The course has previously been delivered for

CRAs/Project Managers
Regulatory Staff
Marketing & Sales Teams in Pharma Companies
Medical Advisers
Medical Communication Professionals

The course has also been tailored for specific therapeutic areas including oncology, respiratory, tissue engineered products and vaccines.

Example Content

Data Types & Summarising Data

Different types of data
Summarising groups of data
Standard deviation, standard error, least square means
Confidence intervals and interpretation

Summarising Data Discrete Data

Odds Ratio
Relative Risk
Absolute Risk
Difference in proportions
Number needed to treat
Number needed to harm

Summarising Data Time to Event Data (survival)

Hazard Rate & Hazard Ratio
Kaplan-Meier Estimates & Plot
Median Time to Event
Proportional Hazards

Summarising Data Continuous Data

Difference in Means
Ratio of means
Non-parametric tests

Hypothesis Testing

Hypotheses to test
What is a p-value?
Statistical tests and p-values (incl logistic regression, chi-squared, Fisher, t-test, ANOVA, log rank, Kaplan-Meier)
Statistical Significance versus Clinical Significance
Equivalence & Non-Inferiority
Interpreting trial results
Exercise: Interpreting results

Power & Sample Size

Definition of Power
Factors involved in sample size
How to sample size
How to reduce sample size when population is limited
Exercise: Hands-on experience of sample sizing

Analysis Populations

What is an analysis population
Intention-to-treat, FAS, All Randomised, Per Protocol
Statistical Analysis Plans

Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here

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Previous Course Feedback: Statistics for Non-Statisticians
Customer: European Pharma Company
Number of Participants: 20
How well fulfilled were your personal objectives for this course?
Fully (75%)
Well (25%)
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How satisfied were you with the Trainer's Style & Knowledge?
Great Deal (100%)
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How much have you learned that you will be able to apply to your job?
Great Deal (80%)
Fair amount (20%)
Not Much (0%)
None At All (0%)
Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.6
Participant Feedback :
I have sat through a number of presentations on medical statistics in my career, and I can honestly say this was the best.
You managed to make the subject understandable and accessible, and the feedback from all the delegates was overwhelmingly positive.
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