Learn Biostatistics for the Non-Statistician
The focus of the seminar is to give you the information and skills necessary to understand statistical concepts and findings as applies to clinical research, and to confidently convey the information to others.
Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.
Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test?
This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.
Emphasis will be placed on the actual statistical (a) concepts, (b) application, and (c) interpretation, and not on mathematical formulas or actual data analysis. A basic understanding of statistics is desired, but not necessary.
Seminar Includes : Certificate , PDF copy of the Handouts , Q/A Session , Live Instructor led 3 Days Web Seminar & Statistical Analysis Plan Template provided by the faculty.
Agenda Day 1: Basics
Session 1: Why Statistics
· Do we really need statistical tests?
· Sample vs. Population
· I’m a statistician not a magician! What statistics can and can’t do
· Descriptive statistics and measures of variability
Session 2: The many ways of interpretation
· Confidence intervals
· Effect sizes
· Clinical vs. meaningful significance
Break - 10 mins
Session 3: Types of Data and Descriptive Statistics
· Levels of data: Continuous, Ordinal, Nominal
· Normal distribution and it’s importance
· Graphical representations of data
· Data transformations, when and how
Break 10 mins
Session 4: Common Statistical Tests
· Comparative tests
· Simple and Multiple regression analysis
· Non-parametric techniques
Agenda Day 2: Special Topics
Session 1: Logistic Regression
· When and why?
· Interpretation of odd ratios
· Presentation of logistic regression analysis and interpretation
· Fun with contingency tables
Session 2: Survival Curves and Cox Regression
· History, theory, and nomenclature of survival analysis
· Kaplan-Meier Curves and Log Rank Tests
· Proportional Hazards
· Interpretation of hazard ratios
· Presentation of KM curves and Cox regression analysis and interpretation
Break 10 mins
Session 3: Bayesian Logics
· A different way of thinking
· Bayesian methods and statistical significance
· Bayesian applications to diagnostics testing
· Bayesian applications to genetics
Break 10 mins
Session 4: Systematic Reviews and Meta-Analysis
· Why perform a systematic reviews and/or meta-analysis?
· A bit of history and reasoning for systematic reviews and/or meta analysis
· Steps in performing a Systematic Review
· Steps in performing a Meta-Analysis
Agenda Day 3: Further Understanding in Clinical Research
Session 1: Other Tests
· Non-Parametric tests
· Test for equivalency
· Test for non-inferiority
Break 10 mins
Session 2: Power and Sample Size
· Theory, steps, and formulas for determining sample sizes
· Demonstration of sample size calculations with GPower software
Session 3: How to Review a Journal Article
· General steps on article review
· Determining the quality of a journal or journal article
· Looking for limitations (all studies have them)
Break 10 mins
Session 4: Developing a Statistical Analyis Plan
· Using FDA (for the U.S. audience) or MHRA (for U.K. audience) guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP)
. An SAP template will be given to all attendees
Who will Benefit:
- Clinical Research Associates
- Clinical Project Managers/Leaders
- Regulatory Professionals who use statistical concepts/terminology in reporting
- Medical Writers who need to interpret statistical reports
- Clinical research organizations, hospitals, researchers in health and biotech fields.
- Persons working in the medical or health sciences, pharmaceutical and or nutriceutical industries, clinical trials, clinical research, and clinical research organizations, physicians, medical students, graduate students in the biological sciences, researchers, and medical writers who need to interpret statistical reports.
The goal of this seminar is to teach you enough statistics to:
• Understand the statistical portions of most articles in medical journals.
• Do simple calculations, especially ones that help in interpreting published literature.
• Avoid being misled by foolish findings.
• Knowledge of which test when, why, and how.
• Perform simple analyses in statistical software.
• Communicate statistical findings to others more clearly.
Testimonials from Clients
"Elaine is absolutely the best, nicest, easiest to work with and the most fabulous statistician that I have worked with. I cannot say enough about her. I have been in academic medicine for 25 years now and founded a small biotech company. With Elaine's help on data, we were just purchased by Sanofi-Aventis, the 3rd largest pharma company! She helped our company so very much and no question was ever left unanswerable. You are making an excellent choice!"
- Resa Levetan, MD - Co-Founder, Cure DM
"Elaine is a wonderful statistics-oriented resource person who has both technical knowledge and business savvy. Having assisted my needs for a quality statistician, Elaine provided me with a well-planned and timely portfolio to aid in my research. She is very personable, and I highly recommend her impeccable data services."
Cirrelia Thaxton, Ph.D - Education