Who Should Attend

This course is designed as an introduction to the statistical principles that form the basis for the design and analysis of research investigations in pharmaceutical and medical device studies.  The focus of topics will benefit individuals within the pharmaceutical, biotech and device industries including medical investigators, basic and clinical research scientists, clinical research associates those involved in regulatory affairs. 

The course will concentrate on the philosophy and understanding of the statistical principles required in conducting sound scientific investigations.  It will not simply present statistical formulae.  Thus, the lectures are oriented toward professionals having little or no formal training in statistics or mathematics.



Learning Objectives

Those completing this course will have an understanding of the concepts and statistical methods required in biological and health science research. They will be able to interpret results related to design and analysis issues as routinely presented in the scientific literature and clinical trials.



Course Description

Introductory Methods  (2 Days). This part of the course will introduce and detail the basic and intermediate statistical concepts that are essential for professionals in a biological, public health or medical environment. The first day will emphasize the principles of descriptive and inferential statistical applications while the second day will focus on actual study examples, problem solving and interpretation of results. Throughout the course, participants are encouraged to ask questions and discuss examples relevant to their own work. The following include but are not limited to topic areas to be discussed.

• Basic statistical terminology needed to effectively communicate with and understand your statistical colleagues
• The statistical essentials required to initiate a research investigation
• Research questions in statistical terms
• Sample size considerations to insure accuracy of conclusions in clinical trials to determine treatment efficacy
• Discussion of statistical techniques to compare experimental approaches or treatment efficacy

Advanced Topics (3rd Day). This section of the course will go cover more complex issues in research investigations and clinical trials.  Topics will include:

• Association studies including correlation and regression analysis with clinical applications
• Examination of Phase I, II and III clinical trials analysis
• Survival analysis and discussion of techniques in bioequivalence and biotherapeutic studies
• Gaining information from multiple studies by meta-analysis

View Course Agenda

Past Participants' Comments

“Best course I’ve ever taken.  CfPIE continues to be a leader in pharmaceutical training.  The instructor was excellent and the hotel accommodations were very nice.  I am excited to use what I have learned!”
James W., Research Associate, ImmunoGen

“This is an excellent course.  It will enable me to at least converse with the statisticians of our company and our external collaborators in a more authoritative manner.”
Stewart G., Research Manager, Unilever

“Great course!  It explained some of the statistical mystery as it applies to my day to day work.”
Souma C., Programmer, Sanofi Aventis

"The course was very helpful in reinforcing my understanding of statistical analysis as it applies to my day-to-day responsibilities in Regulatory.  The class was very well organized in terms of content flow.  The level of detail covered was just right for the varied audience needs."
Cheryl R., Senior Manager, Regulatory Affairs, Celltech Pharmaceuticals

"This is my first course with CfPIE and I am very pleased.  The instructor does a very good job of explaining Biostats and is very easy to follow."
Sofia G., Regulatory Affairs Associate, Genzyme
 
"It was clear the instructor knew the information and he was genuinely interested that participants got their questions answered.  Very well presented!"
Brenda R., Senior Medical Liaison, GSWA
 
"Thank you, I enjoyed the course.  The instructor did a great job, is very enthusiastic and obviously enjoys what he does!"
Research Associate, Aventis
 
"Very thorough overview of difficult material.  Lots of information that I can use immediately." 
Pharmacovigilance Associate, Pfizer
 
"The Course Material and Instructor were better than other courses I've attended.  CFPIE does a much better job in preparing Course Notes than other training providers I've used and has established a new standard in pharmaceutical training"
Senior Clinical Data Mgr., Sepracor

“I think the course director does a great job of presenting some really dry material in an easy to digest and practical way.” 
Kim W., Regulatory Affairs Manager, Beckman Coulter

“Now I have an understanding of how to interpret much of the preclinical data I am working with.” 
Miriam P. Sr. Scientist, Biocompatibility & Preclinical, Cordis Corporation

“Clear overview of the basis of biostatistics. Very useful.”
Sandra O., Manager Clinical Research, Synthon BV