Speakers:

Jim Price is the owner of Strength in Numbers Mathematical and Statistical Services, a consultancy based on the West Coast of Canada. He has nearly 20 years of experience in the Pharmaceutical industry, working at Pfizer, AstraZeneca and a number of smaller companies, predominantly involved in early phase and non-clinical research. In this time he has worked as a Statistician; a modeling and simulation expert in both Pharmacometrics and more generally; and while at AstraZeneca had a free ‘problem solving\’ remit, finding and solving unique issues. For the last 4 years he has been working as a self-employed consultant for a number of small pharma and biotech companies. He holds a MSc in Medical Statistics and Information Technology from Leicester University, and a BSc (hons) in Mathematics and Statistics from the University of Warwick.
Sofia Mosesova
Sofia Mosesova is an Associate Director of Biostatistics at Genentech/Roche, responsible for leading a team of statisticians supporting early clinical development programs in Immunology, Neuroscience, Infectious Disease, Metabolism and Ophthalmology. Sofia has eight years of drug development experience; with a particular focus on projects involving personalized health care (PHC) strategies. Prior to joining Genentech, Sofia worked at PRA International on studies in hematology and pain, and taught undergraduate Statistics courses at four major universities across Canada. Sofia holds PhD and MMath degrees in Statistics from the University of Waterloo, and a BSc in Statistics from Dalhousie University.

Details: 

This workshop will focus on practical aspects of the application of statistics during drug development. Topics to be discussed include:

• Sample versus inferential statistics
• Philosophies behind frequentist and Bayesian statistics
• Statistical models
• Graphical methods to present information
• Experimental designs and sample sizing
• Early phase considerations—first in human, single and muiltiple dose studies
• Later phase statistical considerations—covariate selection strategies, missing data, safety data

The workshop is designed to discuss “common practices”, the theoretical basis behind these practices and practical ideas for implementation in various scenarios