Paid (Fee-Based) Events


Elaine Eisenbeisz, Owner and Principal Statistician of Omega Statistics, is available for training and workshops in statistics, clinical research, process control/quality assurance, and other topics related to statistics and good research practices. Please call or email the Omega Statistics offices to request the latest brochure and pricing for the event(s) that interests you.

Current offerings and scheduled events are listed below.

In addition to the current offerings listed below, Elaine can design an in-house training or virtual webinar to meet your specific needs. Just give her a call at 877-461-7226 or fill out the contact form on this page to leave her a message and she’ll contact you to schedule a time to discuss your needs and how she can help!

Skills Training

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Currently Available Offerings:

2-Day (In-Person or Virtual) Seminars/Workshops:

NOTE: In-person events are not being scheduled at this time

• Biostatistics for the Non-Statistician
• Statistics for Process and Quality Control
• Statistical Elements of Chemistry, Manufacturing, and Controls (CMC)
• Clinical Data Management
• Fundamentals of Clinical Trial Design
• Introduction to Adaptive Design
• Statistical Considerations for ICH Guidelines

6-Hour Virtual Webinars:

• Biostatistics for the Non-Statistician
• Regression and Beyond! Elements of Predictive Modeling in R
• Statistics for Process Control
• Statistics for Quality Control
• Statistical Elements of Post Market Clinical Follow-Up (PMCF)
• Categorical Data Analysis

4-Hour Virtual Webinars:

• Multiple Linear Regression, Logistic Regression, and Survival Analysis
• Applied Time Series Analysis in Health Care
• Statistical Elements of PK/PD Analysis

90 Minute or 2-Hour Virtual Webinars:

• Hypothesis Testing, P-Values, and Inference: When Thinking Like a Statistician Makes Sense
• Is my Data Normal? Normality Tests and Transformations
• Multiple Imputation for Missing Data
• Power Analysis and Sample Size
• Equivalency and Non-Inferioirty Tests
• Preparing a Statistical Analysis Plan
• MedDRA Basics
• Probability Basics
• Statistical Elements of Real-Time qPCR
• Understanding Clinical Trial Reports
• Propensity Score Matching in Observational Studies
• Multiplicity: When and How to Adjust for Multiple Testing
• Calculations for Process and Product Capability
• Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
• ICH-GCP: Elements of Good Clinical Practice

Currently Scheduled Fee Based Events

Omega Statistics has contracted with 3rd party companies to present the following fee based events. The events are listed in chronological order. Please click on the links that interest you to learn more and to register.

Upcoming Events

6-Hour Virtual Webinar: Biostatistics for the Non-Statistician

December 1, 2021

Learn More About the Biostatistics for the Non-Statistician Webinar

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 webinar 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.

The focus of the webinar 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.

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.

90 Minute Webinar: Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

December 8, 2021

Learn More About the Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies Webinar

Verification and validation studies of design-outputs and/or manufacturing processes are required in many manufacturing processes. However, it can be difficult to understand the rational for same sizes used in these contexts. This webinar will be useful to those interested in learning how to make and justify the reasoning behind sample size determination.

This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

Learn the theory, terminology, regulatory requirements, best practices, and of course, the steps for calculating sample sizes for process verification and validation.

NOTE: This webinar does not address rationales for sample sizes used in clinical trials.

90 Minute Webinar: Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

December 9, 2021

Learn More About the Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies Webinar

Verification and validation studies of design-outputs and/or manufacturing processes are required in many manufacturing processes. However, it can be difficult to understand the rational for same sizes used in these contexts. This webinar will be useful to those interested in learning how to make and justify the reasoning behind sample size determination.

This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

Learn the theory, terminology, regulatory requirements, best practices, and of course, the steps for calculating sample sizes for process verification and validation.

NOTE: This webinar does not address rationales for sample sizes used in clinical trials.

90 Minute Webinar: Calculations for Process and Product Capability

January 12, 2022

Learn More About the Calculations for Process and Product Capability Webinar

Companies involved on manufacturing and development perform inspection and testing for acceptance as relates to design, quality, or consumer criteria. These tests and inspections are performed on samples which may be collected at various times in the manufacturing process, including design verification, process validation, or quality control of incoming or outgoing product.

Attendees of this webinar will learn the theory, terminology, regulatory requirements, best practices, and of course, the formulas for calculating common process capability indices used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).

2 Day Virtual Seminar: Statistical Elements of Implementing ICH Guidelines

January 19 & 20, 2022

Learn More About the Statistical Elements of Implementing ICH Guidelines Seminar

Most organizations have programs and procedures but they contain holes or fall short in the implementation of the tools and techniques used to apply proper statistical reasoning and analysis to ICH guidelines. Statistics can help you to better understand, implement, and track processes covered by the ICH guidelines?

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn statistical methods related to ICH guidelines and will discover how regulatory agencies, such as the FDA expect organizations to meet these guidelines.

This seminar will provide attendees with an understanding of the fourteen ICH Quality guidelines as relates to statistical guidance and analysis. The course will provide tools, techniques and insight that will allow participants to immediately begin implementation of the information learned within their organization/firm.

3 Hour Webinar: Applied Time Series in Healthcare

January 26, 2022

Learn More About the Applied Times Series in Healthcare Webinar

Time series models are invaluable to the health care field when it comes to planning and forecasting. Time series models can be used in many aspects of healthcare, including prediction of healthcare expenditures, tracking public health outcomes such as COVID-19, and assessing trends and interventions for patients with hypertension, diabetes, or other chronic diseases.

This 3-hour webinar will provide attendees with the theory and application of time series analysis. The main focus will be on autoregressive integrated moving average (ARIMA) techniques. Variations of the ARIMA and other models which operate under non-linear data, non-stationary data, seasonality, and trends will also be examined.

Examples of times series analyses will be presented using R software. Data and annotated syntax/code will be provided to attendees so they may work the exercises on their own.

2-Day Virtual Seminar: Clinical Data Management (FDA E6 GCP Guidelines)

February 16 and 17, 2022

Learn More About the Clinical Data Management Seminar

Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO).

CDM involves all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of CDM that apply across the board. Review and approval of drugs or devices by regulatory agencies requires the assumption that the data presented are valid and reliable. Integrity of the data is paramount to ensure confidence in the results and conclusions you will make.

This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan. The information conveyed in this course will also assist investigators in setting up processes for smoother data monitoring and auditing.

Examples of CRF’s and required documentation will be presented. Data collection and preparation techniques will also be demonstrated, and will include the use of CDISC and SDTM standards. Additionally, this workshop will provide you with the knowledge and tools needed to assure a CDM plan that holds up when the inevitable deviations from protocol occur.


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