It is important for non-statisticians to become familiar with biostatistics

Statistics is extremely useful as a decision-making tool in the clinical research arena. In areas such as working in a field where a p-value can determine the next steps on development of a drug or procedure, it is very handy, because of which it is imperative for decision makers to understand the theory and application of statistics.
Many statistical software applications have now been developed and made available to professionals. It needs to be borne in mind that these software applications were developed for statisticians, because of which its use can baffle non-statisticians. Their confusions could be as basic as pressing the right key, let alone performing the best test.
A full learning session on biostatistics for the non-statistician

A seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will throw light on the importance of biostatistics for the non-statistician.
Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, who 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; will be the Director of this seminar.
Want to understand the importance of biostatistics for the non-statistician? Then, please enrol for this seminar by visiting It is important for non-statisticians to become familiar with biostatistics. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Statistical concepts in clinical research

Designed essentially for non-statisticians; this seminar provides a non-mathematical introduction to biostatistics. It will be of high value to professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.
Elaine will equip participants of this seminar with the information and skills necessary to understand statistical concepts and findings as they relate to clinical research. With this information, they will be able to confidently communicate with people with whom they need to.
Elaine will place emphasis on the actual statistical concepts, application, and interpretation. She will not go into the areas of mathematical formulas or actual data analysis. A basic understanding of statistics is desired from the participants, but is not necessary.
This course on biostatistics for the non-statistician will help professionals involved in this area, such as Physicians, Clinical Research Associates, and Clinical Project Managers/Leaders, Sponsors, Regulatory Professionals who use statistical concepts/terminology in reporting, and Medical Writers who need to interpret statistical reports.
Elaine’s agenda for this two-day seminar will consist of the following:
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

The many ways of interpretation

• Confidence intervals
• p-values
• effect sizes
• Clinical vs. meaningful significance

Common Statistical Tests

• Comparative tests
• Regression analysis
• Non-parametric techniques

Bayesian Logic

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

Interpreting Statistics – Team Exercise

• Team Exercise: Review a scientific paper and learn how to
  • Interpret statistical jargon
  • Look for reproducibility, transparency, bias, and limitations
  • Convey information coherently to non-statisticians

Study power and sample size

• Review of p-value, significance level, effect size
• Formulas, software, and other resources for computing a sample size

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.

Specialized topics/Closing Comments/Q&A

• Comparing Survival Curves
• Pharmacokinetics/Pharmacodynamics (PK/PD)
• Taking a holistic view to study design and interpretation
• Question and Answer session.

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