Become Better With Biostatistics for the Non-Statistician In 10 Minutes

It is aimed at professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

That statistics can be a vital decision-making tool for clinical research is well-established. It is helpful for the clinician in situations where a p-value can help determine the next steps in the development of a drug or procedure. It is thus vital for decision makers to comprehend the theory and application of statistics.

We have many statistical software applications that help in arriving at crucial decisions. However, almost all these software applications were developed for statisticians. These software applications could confound the non-statisticians. Their confusion could start with something as basic as even knowing which key to press.

In this scenario, learning how to use biostatistics and derive its benefits is important. A marathon, six-hour webinar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, on October 25, will explain biostatistics for the non-statistician.

biostatistics

Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, will be the expert at this webinar. Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-biostatistics-for-the-non-statistician-10307LIVE to register for this webinar.

—————————————————————————————————————-

This webinar, designed for non-statisticians, provides a non-mathematical introduction to biostatistics. Elaine will arm the participants with all the information and skills necessary for understanding statistical concepts and findings as they apply to clinical research, and to confidently convey this knowledge to people with whom they work.

This webinar will emphasize statistical concepts, application, and interpretation, and not on mathematical formulas or actual data analysis. Participants are expected to have an elementary understanding of statistics, but this is not mandatory.

It is aimed at professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

This will be the agenda that will be covered at this webinar:

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.

—————————————————————————————————————–

About the Director:

Elaine brings 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. She has designed the methodology for numerous studies in the clinical, biotech, and health care fields.

She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutraceutical and fitness studies with QPS, a CRO based in Delaware.

GlobalCompliancePanel Virtual Seminars 2018 List For Register Soon

6-Hour Virtual Seminar on Death by CAPA – Does your CAPA Program need a CAPA?

This Virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.

  • Susanne ManzSusanne Manz
  • Time: 09:00 AM PDT | 12:00 PM EDT
  • Duration: 6 Hours
  • Price: $545.00

6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2018

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

6-Hour Virtual Seminar on Applying ISO14971 and IEC62304 – A guide to practical Risk Management

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative.

6-Hour Virtual Seminar on Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing

The Virtual Seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 6 hours is as follows:

6-Hour Virtual Seminar on Statistics for Process Control

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD – Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

6-Hour Virtual Seminar on Statistical Process Control & Process Capability

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified.

6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

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.

6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.

6-Hour Virtual Seminar on Master Class for the HIPAA Officer: Protecting Patient Information and Implementing Today’s Privacy, Security, and Breach Regulations

6-Hour Virtual Seminar on Phase I GMPs

Peggy BerryEarly clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

6-Hour Virtual Seminar on Statistics for Quality Control

Elaine Eisenbeisz

 

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

 

6-Hour Virtual Seminar on GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

Eleonora Babayants

 

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries.

 

Register Soon