Statistical Thinking for Non-Statisticians in Drug Regulation

Delivered by RK Statistics Ltd

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 affairs, statistical programmers and 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.


Level 1

This course is primarily concerned with statistical methodology for the design and analysis of clinical trials, planned and conducted within the pharmaceutical indsutry.

Course topics:

  • Basic issues in Clinical Trial Design - [demo available]
  • 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 – [demo available]
  • Multiple Testing; Problems and Solutions
  • The Analysis of Time to Event Data
  • Equivalence and Non-Inferiority – [demo available]


Level 2

This advanced course follows on from the introductory Level 1 course and covers more advanced topics. The Level 2 course is aimed at the same target audience and has the same primary objective but covers a broaden and more in-depth range of topics.

Course topics:

  • Stratifying the Analysis
  • Modelling Dependence
  • Modelling for Treatment Comparisons – Demo available
  • Missing Data and Imputation
  • Estimands – Demo available
  • Multiplicity 2
  • Bayesian Statistics
  • Meta-Analysis – Demo available
  • Network Meta-Analysis
  • Survival Data 2
  • Observational Studies and Propensity Scoring
  • Statistical Aspects of Safety Data
  • Equivalence and Non-Inferiority 2
  • Adaptive Designs

Learning Objectives: 

The aim of these courses is to enable participants to better understand statistical methodologies used in the design and analysis of clinical studies undertaken within the regulatory environment.
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


Richard Kay

About the author

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. Following this period he moved into the Pharmaceutical Industry with his own consultancy company S-Cubed which was acquired in 1989 by PAREXEL where he spent several years heading up the Statistics function worldwide. He left PAREXEL at the end of 2004 and now works as an Independent Statistical Consultant through his own company RK Statistics Ltd offering statistical consultancy and training services to the industry. 

Richard has worked with PSI since it’s inception, delivering high quality statistical courses and publishing in Pharmaceutical Statistics. He is the editor of the journals Teacher’s Corner. He is Honorary Visiting Professor at the School of Pharmacy and Pharmaceutical Medicine, Cardiff University and is a member of the Faculty of Pharmaceutical Medicine. In 2019 Richard was awarded the President’s Medal by the Faculty for his outstanding contribution to pharmaceutical medicine.

Key highlights

Special discount when signing up through PSI

Level 1 - 12 Hours
Level 2 - 20 Hours

Free demos available

Complete the course in your own time

CPD certified

cpd certified

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