Biostatistics for Non-Statisticians Course: Advanced Training Topics

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Advanced Biostatistics Training for Life Science Professionals

The Center for Professional Innovation and Education's (CfPIE) advanced biostatistical training for non-statisticians outlines the types of clinical investigations conducted, including Phase II (randomized and nonrandomized) and Phase III (randomized) clinical trials. The 15-hour course emphasizes the principles of clinical investigations and common issues that arise. The program also covers the concepts of p-values and power.


As an advanced biostatistics course for non-statisticians, statistical topics will include, but are not limited to:


  • Multiple primary and secondary endpoints in clinical trials and the techniques for addressing proposed multiple testing procedures.
  • Missing data in clinical trials, the types of missing data that can arise and the issues involved for handling and interpreting the results from a lack of data.
  • Adaptive designs in clinical studies when an interim analysis indicates a possible midway correction in study design to preserve the integrity of the study.
  • Addressing the problems of assessing risks in time-to-event studies when failure may be from competing causes. 
  • Complex issues in research investigations and clinical trials.
  • Introduction to Bayesian analysis in clinical studies and their comparison to traditional hypothesis testing procedures.
  • Propensity scoring in the presence of many covariates and the advantages of this technique in various clinical studies.
  • Statistical approaches to high-density data involving genetic markers as diagnostic or treatment correlates.
  • Brief introduction to gaining more information from meta-analysis using meta-regression and other techniques.


The course director introduces topic definitions, followed by a discussion of their impact on clinical studies and the procedures for handling them in context. They will also provide various specific examples.

Why This Course Matters

Data integrity is the backbone of regulatory approval. When learning biostatistics for the drug industry, understanding how data is analyzed is just as critical as the data itself to avoid flawed study designs, failed trials and regulatory rejection. This advanced course bridges the gap between scientific research and statistical rigor, equipping attendees to navigate advanced methodologies with confidence.

Who Should Attend This Biostatistics Course?

This biostatistics course covers advanced statistical principles for the design and analysis of research investigations in pharmaceutical and medical device studies. The focus of topics will benefit individuals in the pharmaceutical, biotech and medical device industries, including:



  • Medical investigators
  • Basic and clinical research scientists
  • Clinical research associates
  • Regulatory affairs professionals


This biotech training program concentrates on the philosophy and understanding of the statistical requirements used in conducting sound scientific investigations. It serves as an essential guide to biostatistics for drug development professionals.

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Advanced Biostatistics Course Curriculum & Testimonials

  • Learning Objectives

    Upon completion of this course, participants will be able to:


    • Grasp clinical research data interpretation for complex trial designs in pharmaceutical, biological, medical device and other health science sectors.
    • Identify and mitigate risks associated with missing data and multiple endpoints.
    • Evaluate the statistical validity of clinical study designs and propose corrections during interim analyses.
    • Apply propensity scoring and meta-analysis techniques to enhance study conclusions.

  • Agenda


    Multiple Primary and Secondary Endpoints: Reasons for composite endpoints, types of multiplicity encountered, design issues, examples of statistical procedures for addressing multiple endpoints, weighting of hypotheses, multiple stage testing procedures.


    Missing Data in Clinical Trials: Types of missing data, mechanisms of missing data (e.g. missing completely at random, missing at random, non-ignorable), consequences of missing data, simple and multiple imputation examples.


    Adaptive Designs: Midway correction techniques, preservation of Type I and Type II errors, two and three stage design examples (randomized and non-randomized), comparison to group sequential (interim analysis only) designs.


    Competing Risk Analysis: Definitions of types of competing risks (CR),Types of trials with CR, the different statistical approaches to CR (advantages, disadvantages), several example comparing performance of these approaches.


    Introduction to Bayes Analysis of Clinical and Epidemiological Studies: Explanation of Bayes methods, Comparison of Bayes methods to traditional statistical approaches to clinical studies such as screening designs, drug development analysis, equivalence studies. Time to event (survival) prediction using Bayes methods. Propensity Scoring in Clinical Trials: Definition and popularity of propensity scoring, the need for propensity measures in place of large sets of covariates, Types of propensity scoring (modeling, matching, stratification) and detailed data examples of each.


    Statistical Approaches to High Density Data Sets: Classification techniques according to diagnostic or treatment assignment outcomes, decision trees, bootstrap forest and boost trees, the role of ROC curves, recent methodology for analysis gene expression data.


    Brief Introduction to Meta-Regression: Methods of meta-regression beyond the usual meta-analysis to determine variables or covariates influencing outcome other than the main treatment /intervention effect, techniques combining both literature data and raw data will be discussed.

FAQs

  • Is this course too technical for non-statisticians?

    Upon completion of this course, participants will be able to:



  • Do I need prerequisites?

    Yes. Attendees should have attended CfPIE's basic biostatistics for non-statisticians course or already have a basic understanding of statistical concepts (like p-values and hypothesis testing).

  • Does this cover both U.S. and EU requirements?

    Yes. The principles covered apply to global clinical investigations, ensuring compliance with both the FDA and the EMA's statistical expectations.

  • Interpret Biostatistical Data With Confidence

    Strengthen your clinical research and gain the advanced insights you need. Add this course to your cart to join our next live session. For custom training programs, call us at 610-648-7550. Request additional course information by contacting us online.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.