The biostatistician plays a crucial role in the process of both drug and device development – from protocol design to data analysis and regulatory submissions. In the early stages of clinical development, the biostatistician is involved in defining the study objectives and the appropriate study design and statistical method which is crucial for success.
The biostatistician is also responsible for defining study endpoints, sample size calculation, interim analysis plans and the hypothesis and testing procedures which are defined in the Statistical Analysis Plan (SAP).
The biostatistician works closely with the rest of the biometrics team throughout the study including Data Managers, Statistical Programmers and Medical Writers.
This course is offered to clinical trial professionals who wish to comprehend the role of statistics and statisticians in clinical trials. The course aims to enhance one’s understanding of basic statistical principles as well as the statistician’s view on clinical trial aspects.
The course will have practical sections after each topic to support the comprehension with class exercises.
Who is this course designed for?
Medical Directors, Heads of Clinical Operations, CRAs, Data Managers, Medical writers, Clinical scientists and clinical professionals in the Pharmaceutical, Biotechnology and Medical Device sectors willing to strengthen the statistics background.
- Stages of drug development overview and study designs
- Descriptive Statistics
- Type of parameters
- Inferential statistics
- P-values, confidence intervals
- Test for hypothesis testing
- Sample size, power calculation
- Q&A and Conclusions
Workshop: Practice on randomization, descriptive statistics, simulation of population inference, confidence intervals, hypothesis testing, power calculation, precision calculation.
Interactive lessons with case studies and classroom exercises
At the end of the training, you will be able to:
- Understand key concepts in clinical trial statistics.
- Understand how statistics are reflected in the design of clinical trials.
- Recognize and understand key statistical terminology including sample size calculation, confidence intervals, power calculation.
- Understand more effectively the role statistics play in clinical trials and communicate the study results.
Tri Tat, Principal Biostatistician at CROS NT
Nineteen years of experience as a statistician in both pharmaceutical industry and academic medical departments. Worked in early phase safety and tolerability, phase II dose-ranging and proof-of-concept, phase III confirmatory trials, and public health observational trials. Planned and performed statistical analyses in therapeutic drug trials (including cancer, urology, cardiovascular, diabetes, arthritis, and age-related macular degeneration), as well as, device trials, health surveys and health economic evaluations. Major responsibilities held include lead trial statistician, DSMB statistician, statistical consultancy, peer review and teaching statistics. Expert programming knowledge in SAS, R and BUGS.