Online Courses
The course 'Statistical Thinking for Non-Statisticians in Drug Regulation' is available on-line.
The course is aimed at non-statisticians working in the Pharmaceutical Industry and is suitable for physicians, medical science liaison (MSL), medical writers, clinical research scientists, 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. Further details can be found below, and at https://www.rkstatisticstraining.com
The structure and content of this course has been built around the 3rd edition of Richard Kay’s book ‘Statistical Thinking for Non-Statisticians in Drug Regulation’ published by Wiley (https://www.wiley.com/en-ie/Statistical+Thinking+for+Non+Statisticians+in+Drug+Regulation%2C+3rd+Edition-p-9781119867388).
The online CPD certified course is split into two parts:
Part 1/Level 1 consists of 10 lectures providing a comprehensive coverage of the basic ideas:
Part 2/Level 2 consists of 14 lectures and covers additional material and a more in-depth coverage of several of the Part 1 topics
Feedback:
“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 – Freelance Medical Writer (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).
"Thanks a lot, I found the course with Dr Richard Kay very interesting and relevant to the type of studies conducted at the hospital where I work. To me, I was a great advantage that handouts were available to add own notes and that I could ‘replay’ some of the slides. I also appreciated the “Would you like to continue where you left off” option which I used a couple of times during each module. The level of detail seemed very appropriate to me." Hanne Birgitte Hede Jørgensen - AC-medarbejder, ledelsessupporter, PhD (Denmark)
For further information on the course content and to sign up for the course follow this link: https://www.rkstatisticstraining.com
The course is aimed at non-statisticians working in the Pharmaceutical Industry and is suitable for physicians, medical science liaison (MSL), medical writers, clinical research scientists, 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. Further details can be found below, and at https://www.rkstatisticstraining.com
The structure and content of this course has been built around the 3rd edition of Richard Kay’s book ‘Statistical Thinking for Non-Statisticians in Drug Regulation’ published by Wiley (https://www.wiley.com/en-ie/Statistical+Thinking+for+Non+Statisticians+in+Drug+Regulation%2C+3rd+Edition-p-9781119867388).
The online CPD certified course is split into two parts:
Part 1/Level 1 consists of 10 lectures providing a comprehensive coverage of the basic ideas:
- Basic Issues in Clinical Trial Design
- 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
- Multiplicity
- The Analysis of Survival Data
- Equivalence and Non-Inferiority
Part 2/Level 2 consists of 14 lectures and covers additional material and a more in-depth coverage of several of the Part 1 topics
- Stratifying the Analysis
- Modelling Dependence
- Modelling for Treatment Comparisons
- Missing Data and Imputation
- Estimands
- Multiplicity (Level 2)
- Bayesian Statistics
- Meta-Analysis
- Network Meta-Analysis
- Survival Data (Level 2)
- Observational Studies and Propensity Scoring
- Statistical Aspects of Safety Data
- Equivalence and Non-Inferiority (Level 2)
- Adaptive Designs
Feedback:
“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 – Freelance Medical Writer (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).
"Thanks a lot, I found the course with Dr Richard Kay very interesting and relevant to the type of studies conducted at the hospital where I work. To me, I was a great advantage that handouts were available to add own notes and that I could ‘replay’ some of the slides. I also appreciated the “Would you like to continue where you left off” option which I used a couple of times during each module. The level of detail seemed very appropriate to me." Hanne Birgitte Hede Jørgensen - AC-medarbejder, ledelsessupporter, PhD (Denmark)
For further information on the course content and to sign up for the course follow this link: https://www.rkstatisticstraining.com