Statistical Thinking for Non-Statisticians in Drug Regulation

Online Training Id: ST1



GBP 500.00

GBP 500.00

This course is primarily concerned with statistical methodology for the design and analysis of clinical trials, planned and conducted within the pharmaceutical industry. Much of the methodology presented is in fact applicable on a broader basis and can be used in observational studies and in clinical trials outside of the pharmaceutical sector; nonetheless the primary context is clinical trials and pharmaceuticals. The course is aimed at non-statisticians working in the Pharmaceutical Industry and will be suitable for physicians, investigators, clinical research scientists,medical science liaison (MSL), medical writers, regulatory personnel, statistical programmers and senior data managers. Statisticians moving from other areas of application outside of pharmaceuticals may also find the course useful in that it places the methods that they are familiar with in context for their new environment.

Course topics:

  • Basic Issues in Clinical Trial Design - View Demo
  • Sampling and Inferential Statistics
  • Confidence Intervals and p-Values
  • Intention to Treat, Analysis Sets and Missing Data
  • Diagnosis
  • Tests for Simple Treatment Comparisons
  • Power and Sample Size - View Demo
  • Multiple Testing; Problems and Solutions
  • The Analysis of Time to Event Data
  • Equivalence and Non-Inferiority - View Demo

Learning Objectives: 

The aim of this course is not to turn non-statisticians into statisticians. You should not expect to go away from this course and be able to ‘do’ statistics.
The aims of the course are four-fold:

  • 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

Who Should Enroll:

Pharmaceutical physicians, investigators, clinical research scientists, medical science liaison (MSL), medical writers, regulatory personnel, statistical programmers and senior data managers.

The structure and content of this course has been built around the two-day Postgraduate Diploma in Pharmaceutical Medicine Medical Statistics module, organized and run jointly by Cardiff University in the UK and the British Association of Pharmaceutical Physicians (BrAPP). The topics covered are consistent with the PharmaTrain Syllabus for Pharmaceutical Medicine/Medicines Development Science. 

Our Testimonials

“During education, we sometimes stumble upon topics that give us a ‘brain freeze’. They become something we avoid encountering at all costs. For me, biomedical statistics was one of those topics along with such ‘villains’ as the Krebs cycle and coagulation cascade. 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 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)

"Thank you, Richard!
Yes, I enjoyed the course - I signed-up for your course because it has been 10 years since I completed a Dutch-language masters in epidemiology (Dutch is a second language; I'm a native English speaker) and I hadn't actively used this knowledge for a while. I now work as a freelance medical writer and I wanted to be sure I would be able to explain and summarise study results correctly. Revisiting the concepts in English 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)

"Thank you, Richard!
Yes, I enjoyed the course - I signed-up for your course because it has been 10 years since I completed a Dutch-language masters in epidemiology (Dutch is a second language; I'm a native English speaker) and I hadn't actively used this knowledge for a while. I now work as a freelance medical writer and I wanted to be sure I would be able to explain and summarise study results correctly. Revisiting the concepts in English 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)

"I did do most of the online course, I had only missed the 2nd half of Richards course so had all the notes. 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. I would say it is a brilliant substitute for the face to face but not an extra/supplement to the usual course. I used his online modules as my core learning supplemented with his brilliant book if I wanted more detail/ practical examples."

Emma Smith, Janssen Pharmaceuticals(UK)

"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)

"It was a great chance to attend this well designed and informative course.
Thanks Richard Kay for your effort."

Mariam Amin - Assistant Lecturer of Public Health at Assiut University ( Egypt)


Dr Richard Kay  PHD

Richard Kay has spent over forty years working in medical statistics. Following his PhD work at the London School of Hygiene he spent fifteen years in academia undertaking teaching and research at the Universities of Salford, Heidelberg and Sheffield.

Richard moved out of the academic environment in 1989 to set up his own company, S-Cubed, based in Sheffield, offering statistics and data management services to the pharmaceutical industry. After a period of growth he merged his company with PAREXEL in 1997 and, while continuing to help grow the Sheffield facility, he took on the management and direction of the Biostatistics and Programming function worldwide for PAREXEL from 1999. In January, 2005 he left PAREXEL to work as an Independent Statistical Consultant and from 2009 he has headed up his own company RK Statistics Ltd offering statistical consultancy and training services to the pharmaceutical industry.

Richard is Honorary Visiting Professor at the School of Pharmacy and Pharmaceutical Medicine, Cardiff University in the UK and is a member of the Faculty of Pharmaceutical Medicine. He is also an editor of the journal Pharmaceutical Statistics.



Online Training Highlights
Duration: 12 hrs
Released On: 02/15/2018
Downloadable Resources: 
Watch a Demo
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