Course "Biostatistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Why should you attend:

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.

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.

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.

Who will benefit:

• Physicians
• Clinical Research Associates
• Clinical Project Managers/Leaders
• Sponsors
• Regulatory Professionals who use statistical concepts/terminology in reporting
• Medical Writers who need to interpret statistical reports

Day 1 Schedule

Lecture 1 (90 Mins):

Why Statistics?

• Do we really need statistical tests?
• Sample vs. Population
• Statistician ≠ Magician. What statistics can and can't do.
• Descriptive statistics & measures of variability.

Lecture 2 (90 Mins):

The many ways of interpretation

• P-values
• Effect sizes
• Confidence intervals
• Statistical vs. Meaningful significance

Lecture 3 (90 Mins):

Common Statistical Tests

• Why Test? Null Hypothesis Significance Testing (NHST)
• Comparative tests
• Correlation
• Multiple Regression analysis
• Non-parametric techniques

Lecture 4 (90 Mins):

Bayesian Logic

• A different way of thinking
• Bayesian methods and statistical significance
• Bayesian applications to diagnostics testing
• Bayesian applications to genetics

Day 2 Schedule

Lecture 1 (90 Mins):

Interpreting Statistics - Team Exercise

• Team Exercise: Review a scientific paper and learn how to

o    Interpret statistical jargon

o    Look for reproducibility, transparency, bias, and limitations

o    Convey information coherently to non-statisticians

Lecture 2 (90 Mins):

Study power and sample size

• Review of p-value, significance level, effect size and how they are use in sample size calculations
• Formulas, software, and other resources for computing a sample size.

Lecture 3 (90 Mins):

Developing a Statistical Analysis Plan

• Using FDA 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.

Lecture 4 (90 Mins):

Specialized topics/Closing Comments/Q&A

• Logistic Regression.
• Comparing survival curves
• Cox Regression
• Question and answer session.

Speaker:

Elaine Eisenbeisz

Owner and Principal Statistician, Omega Statistics

Elaine Eisenbeisz, is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers.

In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.

Elaine's love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics with a minor in Quantitative Management, Accounting. Elaine received her Master's Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.

Location: San Diego, CA Date: March 14th & 15th, 2019 and Time: 9:00 AM to 6:00 PM

Venue:  DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA

Price:

1 ATTENDEE $2,000, Register for 1 attendee

5 ATTENDEES $10,000, Register for 5 attendees

10 ATTENDEES $20,000, Register for 10 attendees

Until February 14, Early Bird Price: $2,000. From February 15 to March 12, Regular Price: $2,200

use this promo code GCP50 to get 50% off.