Statistical Thinking for Non-Statisticians in Drug Regulation

Delivered by RK Statistics Ltd

ENROL NOW and receive a 10% discount

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

Duration:
Level 1 - 12 Hours
Level 2 - 20 Hours

Free demos available

Complete the course in your own time

CPD certified

cpd certified
 

Upcoming Events

PSI Training Course: Regulatory Guidelines for Statisticians

Dates: Wednesday 2nd & Thursday 3rd October 2024 This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Efficient R&D: SVEM and Advanced DOE in Preclinical Toxicity Testing

Date: Tuesday 8th October 2024 This 1-hour webinar will be an opportunity to hear how JMP have been influential in the toxicity testing of an oncology formulation in a pre-clinical setting. At the end of the presentation there will also be the opportunity to ask questions.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Date: The Second Wednesday of every Month Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

Joint PSI/EFSPI Small Populations & RWD SIG Webinar: Harnessing Real-World Data (RWD) in clinical trials for small populations and rare diseases

Date: Thursday 17th October 2024 In this webinar we will review the range of statistical methodologies used to harness the potential of Real-World Data (RWD) in clinical development, particularly in the context of rare diseases and small populations like paediatrics. The session will include theoretical understanding and practical case studies, with a special focus on Bayesian methods and causal inference.

PSI Webinar: Hierarchical composite endpoints in clinical trials: challenges & opportunities

Date: Wednesday 23rd October 2024 In this event, we’ll start with a general introduction to hierarchical composite endpoints and an overview of common analysis methods including win ratio, win odds, and net benefit. Then, the practical considerations will be illustrated through case studies from clinical trials in heart failure and chronic kidney disease. We conclude with a discussion and a Q&A.

PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics

Date: Wednesday 6th November 2024 A careers talk about medical statistics and how it plays a crucial role in developing new medicines

Joint PSI/EFSPI Causal Inference SIG Webinar: Opportunities in applying a causal inference framework during the analysis of an RCT

Date: Tuesday 19th November 2024 This webinar will discuss opportunities in applying causal inference methodology during the analysis of RCT data.

PSI Training Course: Introduction to Bayesian Methods

Dates: Module 1 - Wednesday 20th November Module 2 - Tuesday 26th November Module 3 - Thursday 28th November This interactive and hands on online course, aimed at beginner Bayesians who have little or no experience in Bayesian statistics, is split into 3 modules. Module 1 introduces Bayesian concepts and looks at how Bayes has been used recently in the Pharmaceutical Industry, and participants will undertake their own data collection exercise in order to analyse a simple Bayesian trial. Module 2 takes a look at the concepts of Bayesian statistics and key terminology and provides a chance to analyse some data using a simple Bayesian approach. Module 3 takes a further look at the use of Bayesian statistics in drug development and regulatory requirements and digs deeper into analysis issues.

PSI Medical Statistics Student Careers Event 2024

Date: 20 October 2024 This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

Date: Re-scheduled to Tuesday 26th November 2024 Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.

PSI Career Young Virtual Event (Q4 2024)

Date: Tuesday 10th December 2024 This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

Date: October 2024 - July 2025 An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

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