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Dr. Richard Kay
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Level 1 — Free Preview Lessons Statistical Thinking for Non-Statisticians in Drug Regulation
DEMO 1

Basic Issues in Clinical Trial Design

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Level 1 · Module 1 — Randomisation, blinding, phases of clinical trials and fundamental design principles.
DEMO 2

Power and Sample Size

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Level 1 · Module 7 — How sample size is calculated, what power means and why it matters in trial design.
DEMO 3

Equivalence and Non-Inferiority

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Level 1 · Module 10 — Non-inferiority margins, biosimilar trials and equivalence testing explained clearly.

“I found the online course pretty much an exact replica of what he delivers in person. Clear, concise, digestible and I liked the modular format being able to take it at my own pace.”

Emma Smith, Janssen Pharmaceuticals (UK)

Level 2 — Free Preview Lessons Advanced Statistical Methods in Drug Regulation
DEMO 4

Modelling for Treatment Comparisons (ANCOVA)

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Level 2 · Module 3 — ANCOVA, least squares means, treatment interactions and regression to the mean.
DEMO 5

Estimands & ICH E9(R1)

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Level 2 · Module 5 — What estimands are, why they matter under ICH E9(R1) and the five estimand strategies explained.
DEMO 6

Meta-Analysis

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Level 2 · Module 8 — Fixed and random effects, heterogeneity, forest plots and publication bias.
DEMO 7

Adaptive Designs

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Level 2 · Module 14 — Seamless designs, type I error control, sample size adaptation and enrichment strategies.

“I have really enjoyed the course as it refreshed my quite older knowledge and helped me be aware some of the newer insights. Good examples were included that were exactly demonstrating the different aspects in the course. Thank you!”

Linda Rutgrink, Regional Trial Manager at Sanofi (Netherlands)

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Online Training - Statistical Thinking for Non-Statisticians in Drug Regulation

Why should you enroll?

To help in the critical review of reports and publications

To help in the understanding of statistical methods used in presentations at congresses and meetings

To aid communication between statisticians and non-statisticians

To enable the more effective use of statistical arguments in general discussions and in interactions for example with investigators and regulators

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CPD Certified

CPD certified

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What we offer

Statistical Understanding

Statistical Understanding

Critical review of reports and publications. Understanding statistical methods used in presentations. Enable the more effective use of statistical arguments in general discussions and interactions with investigators and regulators

Professional Development

Professional Development

Become a more competent and effective pharma professional. Our courses are CPD certified and focused for an individual to improve and have effective professional development.

More Career Opportunities

Career Opportunities

Get access to a downloadable PDF Certificate for the course upon successful completion. Share your achievement with your professional network and create more career opportunities.

Our Testimonials

“I did do most of the online course. I found the online course pretty much an exact replica of what he delivers in person as all the notes and examples are the same. Clear, concise, digestible and I liked the modular format being able to take it at my own pace it made it seem more manageable.”

Emma Smith, Janssen Pharmaceuticals (UK)

“I have really enjoyed the course as it refreshed my quite older knowledge and helped me be aware some of the newer insights. Good examples were included that were exactly demonstrating the different aspects in the course. Thank you!”

Linda Rutgrink, Regional Trial Manager at Sanofi (Netherlands)

“Thanks, Richard. I found the course very useful. This course is unusual in using words and examples, rather than equations, to explain the implications and applications of statistical tests. It explains how to interpret, not conduct, statistical tests and the quizzes dotted throughout the course refer usefully to the same published article, which further brings the concepts to life.”

Sally Watcham (Swedish Orphan Biovitrum AB)

“During education, we sometimes stumble upon topics that give us a ‘brain freeze’. They become something we avoid encountering at all costs. Yet Dr. R. Kay’s course, concise and comprehensible, dispelled the curse in a truly painless way. Highly recommended.”

Migle Janeliuniene, Medical Writer at Biomapas (Lithuania)

“I now work as a freelance medical writer and wanted to be sure I would be able to explain and summarise study results correctly. Revisiting the concepts through your course was very helpful in solidifying my understanding and I feel I achieved my learning goal. Thanks again.”

Kimi Uegaki - Medical Writer (Netherlands)

“Thanks a lot, I found the course with Dr. Richard Kay very interesting and relevant. I would like to receive information on the Level 2 course.”

Hanne Birgitte Hede Jørgensen - AC-medarbejder (Denmark)