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BIOSTATISTICS FOR THE NON-STATISTICIAN TRAINING COURSE

3 DAY VIRTUAL SEMINAR

OCT 18-20, 2021 TIME 12:00 PM EDT - 05:00 PM EDT

DURATION 12 HRS PLUS INTERACTIVE WEB SEMINAR

Both Live and On Demand Recorded Options Available

Purchase Options


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

·     p-values

·     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 

Q&A

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

·     Terminology

·     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:

 * 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
 * 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.


LEARNING OBJECTIVES

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



CHOOSE A PURCHASE OPTIONS




$1,898.05


ONE DIAL-IN ONE ATTENDEE - LIVE

EARLY BIRD $1595 REGULAR PRICE $1985

Less

You'll have access to single log-in of the entire 3 day virtual seminar live
including the Q&A period, for single participant. You'll also receive all
presentation materials.




$5,551.35


GROUP-MAX. 5 ATTENDEES - LIVE + 90 DAYS ACCESS

3 DAY VIRTUAL SEMINAR

More

You get Group log-in for the live virtual seminar for 5 participants,
presentation materials , Certificate and the opportunity to ask questions by
phone and email. On Demand Recorded Access is Included for 90 days for the
Group.

$2,017.05


RECORDED ON DEMAND ONE ATTENDEE

EARLY BIRD $1695 REGULAR PRICE $2095

More

3 DayVirtual Seminar . You get one log-in for the On Demand Recorded Access
for 3 day virtual seminar for one participant includes presentation materials ,
Certificate and the opportunity to ask questions by phone and email. Access
valid for 12 months.

$5,944.05


24/7 ENCORE PRESENTATION - 3 DAY SEMINAR

CORPORATE MULTIPLE USER ACCESS

More

You'll have access to group log-in for an archived recording of the entire 3 day
virtual seminar including the Q&A period, for unlimited participants. You can
log in any time of day or night. You'll also receive all presentation materials

Register Now

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.

UPCOMING PHARMACEUTICAL & MEDICAL DEVICE TRAININGS ONLINE IN 2021


COMPUTER SYSTEM VALIDATION PROFESSIONAL CERTIFICATION PROGRAM 3 DAYS



MP3 DOWNLOAD THIS COURSE WILL COMPLETELY IMMERSE YOU IN COMPUTER SYSTEM
VALIDATION AND DELIVERS COMPREHENSION OF THE REGULATIONS IMPACTING YOUR SYSTEM

Carolyn Troiano

% COMPLETE

€1.541,05


A COMPREHENSIVE VIEW OF MEDICAL DEVICE POST-MARKET REGULATIONS AND CHALLENGES
DURING COVID-19— COMPLAINT HANDLING, MDR REPORTING AND RECALLS



OCT 21 - 22 THIS COURSE WILL EXPLAIN HOW TO COMPLY WITH COMPLICATED COMPLAINT
HANDLING, MDR AND RECALL REQUIREMENTS. EARL BIRD. REGISTER.

Rita Hoffman

% COMPLETE

$1,782.62


TECHNICAL WRITING FOR PROFESSIONALS IN THE LIFE SCIENCES



OCT 05 -07 THIS VIRTUAL SEMINAR WILL WALK YOU THROUGH THE TECHNICAL WRITING
PROCESS FROM START TO FINISH. EACH CRITICAL ASPECT OF WRITING TECHNICAL
DOCUMENTS

Charles H. Paul

% COMPLETE

$1,779.05

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