Statistics is a useful de cision 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 an d application of statistics.

\n\nMany statistical softwares are now available to professionals. However\, these softwares were developed for s tatisticians and can often be daunting to non-statisticians. How do you kn ow if you are pressing the right key\, let alone performing the best test?

\n\nThis seminar provides a non-mathematical introduction to biosta tistics and is designed for non-statisticians. And it will benefit profess ionals who must understand and work with study design and interpretation o f findings in a clinical or biotechnology setting.

\n\nThe focus of the seminar is to give you the information and skills necessary to underst and statistical concepts and findings as applies to clinical research\, an d to confidently convey the information to others.

\n\nEmphasis will be placed on the actual statistical (a) concepts\, (b) application\, and (c) interpretation\, and not on mathematical formulas or actual data analy sis. A basic understanding of statistics is desired\, but not necessary.\n\n

\n

- \n
- Physicians \n < li>Clinical Research Associates\n
- Clinical Project Managers/Leade rs \n
- Sponsors \n
- Regulatory Professionals who use statist ical concepts/terminology in reporting \n
- Medical Writers who need to interpret statistical reports \n

Lecture 1 (90 Mins):\n

**Why Statistics?**

Lecture 2 (90 Mins):\n

**The many wa
ys of interpretation**

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

Lecture 3 (90 Mins):\n

**Common
Statistical Tests**

- \n
- Comparative tests \n
- Regression analysis \n
- Non-parametric techniques \n

**Bayesian Logic**

- \n
- A different way of thinking \n
- Bayesian methods and statistic al significance \n
- Bayesian applications to diagnostics testing\n
- Bayesian applications to genetics \n

\n

Lecture 1 (90 Mins):\n

**Interpreting Stati
stics &ndash\; Team Exercise**

- \n
- Interpret statistical jargon \n
- Look for reproducibility\, transparency\, bias\, and limitations\n
- Convey information coherently to non-statisticians \n

Lecture 2 (90 Mins):\n

**Study power and sample size**

- \n
- Review of p-value\, significance level\, effect size< /li>\n
- Formulas\, software\, and other resources for computing a sampl e size \n

Lecture 3 (90 Mins):\n

**Developing a
Statistical Analysis Plan**

- \n
- Using FDA guidance as a foundation\, learn the steps and criteria needed to develop a statistic al analysis plan (SAP). \n
- An SAP template will be given to all at tendees. \n

Lecture 4 (90 Mins):\n

**Specialized
topics/Closing Comments/Q&\;A**

- \n
- Comparing Sur vival Curves \n
- Pharmocokinetics/Pharmacodynamics (PK/PD) \n < li>Taking a holistic view to study design and interpretation\n
- Qu estion and Answer session \n

\n \;\n

**<
strong>Elaine Eisenbeisz\,** \;is a private practice statistici
an and owner of Omega Statistics\, a statistical consulting firm based in
Southern California. Elaine has over 30 years of experience in creating da
ta and information solutions for industries ranging from governmental agen
cies and corporations\, to start-up companies and individual researchers.<
/p>\n\n

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

\n\nElaine'\;s love of numbers began in elementary school where she placed in regional and statewide mathematics c ompetitions. She attended University of California\, Riverside\, as a Nati onal Science Foundation scholar\, where she earned a B.S. in Statistics wi th a minor in Quantitative Management\, Accounting. Elaine received her Ma ster'\;s Certification in Applied Statistcs from Texas A&\;M\, and i s currently finishing her graduate studies at Rochester Institute of Techn ology. Elaine is a member in good standing with the American Statistical A ssociation 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.

\n\nElaine has designed the methodo
logy for numerous studies in the clinical\, biotech\, and health care fiel
ds. She currently is an investigator on approximately 10 proton therapy cl
inical trials for Proton Collaborative Group\, based in Illinois. She also
designs and analyzes studies as a contract statistician for nutriceutical
and fitness studies with QPS\, a CRO based in Delaware. Elaine has also w
orked as a contract statistician with numerous private researchers and bio
tech start-ups as well as with larger companies such as Allergan and Rio T
into Minerals. Not only is Elaine well versed in statistical methodology a
nd 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 Statistic
s website at www.OmegaStatistics.com to learn more about Elaine and Omega
Statistics.

\n

\nPlease contact Marilyn Turner: Phone: +1 929 90
0 1853 \;Email: marilyn.turner [a] nyeventslist.com for registrations