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Learn clinical biostatistics course for the Non-Statistician
The objective of this seminar is to provide every trainee with the information and skills that are mandatory to comprehend numerical concepts and answers as smears to scientific study and to positively convey the information to others.
Statistics is a valuable tool that is good and useful for making decisions in the medical research arena. When employed in a field where a p-value can determine the next steps in the development of a drug or procedure, it is authoritative that choice makers comprehend the philosophy and request of statistics.
Quite a few numerical software is now available to professionals. However, this software was industrialized for geometers and can often be unnerving to non-statisticians. How do you know if you are persistent in the right key, let unaided execution be the best test?
This seminar on medical biostatistics online course provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will profit specialists who must comprehend and work with study design and clarification of findings in a scientific or biotechnology setting.
Stress will be placed on the real numerical (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
▪ Self-assurance intervals
▪ P-values
▪ Effect sizes
▪ Clinical vs. meaningful significance
Break - 10 mins
Session 3: Types of Data and Descriptive Statistics
▪ Levels of data: Incessant, Ordinal, Trifling
▪ Normal delivery and its standing
▪ Pictorial representations of data
▪ Data alterations, when and how
Break 10 mins
Session 4: Common Statistical Tests
▪ Relative tests
▪ Simple and Manifold reversion examination
▪ Non-parametric methods
Q&A
Agenda Day 2: Special Topics
Session 1: Logistic Reversion
▪ When and why?
▪ Clarification of odd ratios
▪ Performance of logistic reversion analysis and clarification
▪ Fun with eventuality 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: Methodical Appraisals and Meta-Analysis
▪ Why is doing a methodical review and/or meta-analysis important?
▪ A bit of history and reasoning for systematic reviews and/or meta-analysis
▪ Vocabulary
▪ 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
▪ Concept, steps, and plans for decisive sample sizes
Display of sample size calculations with G-Power software
Session 3: How to Review a Journal Article
▪ Overall steps on object evaluation
▪ Defining the quality of a periodical or journal article
▪ Looking for limitations (all studies have them)
Break 10 mins
Session 4: Developing a Statistical Analysis Plan
▪ Using FDA (for the U.S. audience) or MHRA (for the 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 is supposed to get the benefit?
▪ Physicians
▪ Medical Writers who need to interpret statistical reports
▪ Clinical Project Managers/Leaders
▪ Clinical Research Associates Sponsors
▪ Regulatory Professionals who use statistical concepts/terminology in reporting
▪ Clinical research organizations, hospitals, and researchers in health and biotech fields.
▪ People engaged in the medical sciences, medicinal and or nutraceutical industries, scientific trials, scientific research, and clinical research administrations, physicians, medicinal students, graduate students in the biological sciences, researchers, and medical writers who need to interpret statistical reports.
Learning objectives
The aim of this seminar is to educate you on enough statistics to:
- Perform simple analyses in statistical software.
- Avoid being misinformed by unwise findings.
- Communicate statistical findings to others more clearly.
- Comprehend the numerical portions of the greatest articles in medical journals.
- Do simple calculations, particularly ones that aid in interpreting published literature.
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Knowledge of which test when, why, and how.
Elaine Eisenbeisz
Statistician ( 30 + yrs exp.)
Owner & Principal of Omega Statistics
Murrieta, California, United States
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. She 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.
Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She has served as an investigator on many oncology trials. She also designs and analyzes studies as a contract statistician for pharmaceutical, nutriceutical and fitness companies and various clinical research organizations. Her work includes design and analysis for numerous private researchers and biotech start-ups as well as with larger companies such as Intutive, Allergan, and Rio Tinto Minerals. Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.
12.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 12.0 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
