Monday, October 3, 2022  9:00 - 5:01 pm

W1: Biostatistics for Beginners - IN-PERSON ONLY

Detailed Agenda
Biostatistics is the science of learning from biological data. Inferential statistics use data from a sample to make generalizations or predictions about a population. The process of sampling naturally incurs error and statistics are needed to measure, control, and communicate the uncertainty of reported results. This workshop is intended for people who generate or review bioassay data, but have minimal training in statistics. This slower-paced course will help participants understand the meaning of commonly encountered statistical information and expand their knowledge of fundamental concepts and tools that are applicable to their daily work.
Nancy Sajjadi, Independent Quality Consultant, Sajjadi Consulting
Ralf Stegmann, PhD, Stegmann Systems GmbH

Biostatistics for Beginners

Nancy Sajjadi, Independent Quality Consultant, Sajjadi Consulting


  • USP <1033> – What Does It Mean for a Bioassay to be “Suitable for Intended Use”?
  • The Role of Statistics in the Development of Biologics and Lot Release Specifications
  • Assays, Measurements, Averaging, and the Meaning of Uncertainty·        
  • Accuracy vs Precision
  • Populations vs Samples
  • Parameters vs Statistics
  • The Normal Distribution
  • Inferential Statistics and Sampling Error
  • Standard Error of the Mean
  • t values and p values
  • Confidence Intervals
  • Difference vs Equivalence Testing
  • Type I and Type II Errors and Statistical Power
  • Dose-Response Curve Models
  • Log Transformation of Bioassay Readouts and Relative Potency Values
  • Selecting Software for Bioassay Analysis
  • Interpreting ICH Assay Validation Guidance
  • Critical Fold Difference as a Metric for Evaluating Bioassay Precision to Support Early Phase Trials

The commitment to participants: Each participant is likely to arrive at the course with the expectation of examples or explanations to address issues that are specific to them or their organization. To ensure that participants are satisfied, the instructor is open to receiving non-confidential questions in advance for consideration in customizing the course material. The instructor will assess each question to ensure it matches the scope of the workshop. If you have question(s) the instructor should address at the workshop, email them to Kaitlyn Barago, Workshop Organizer at


  • Laboratory scientists, technicians, and others with limited statistical knowledge who are involved in generating and reporting data
  • Managers in QA, QC, and Regulatory functions who review data and statistical analyses
  • Non-statisticians who engage with statisticians in the design and interpretation of studies
  • Technicians involved in design, execution, or review of assay qualification protocols
  • Anyone interested in increasing their understanding of basic statistical concepts and improving their comprehension of conference presentations that include statistical analyses


ROOM LOCATION: Arlington Salon VI

9:00 am

Start of Workshop

11:40 am

Networking Coffee Break

12:00 pm

Workshop Resumes

1:00 pm LUNCHEON WORKSHOP:PLA 3.0 – Features and Latest Updates

Ralf Stegmann, PhD, Stegmann Systems GmbH

Short presentation about the basic features of the PLA 3.0 system and a brief introduction into the capabilities of the latest PLA 3.0 add-ons including the latest versions of the Biological Assay Package, Dose-Response Analysis Package, Biological Assay Simulation Package, and the brand-new Control Chart Package for statistical process control.


2:15 pm

Workshop Resumes

3:30 pm

Networking Refreshment Break

3:50 pm

Workshop Resumes

5:00 pm

Close of Workshop


Nancy Sajjadi, Independent Quality Consultant, Sajjadi Consulting

Nancy Sajjadi, M.Sc. is Founder and Principal Consultant of Sajjadi Consulting. She has over 30 years of experience in biopharmaceutical product development. She began her career as a bench scientist doing malaria vaccine research then joined a start-up company developing cell and gene using therapies for infectious disease, cancer and cell therapy applications. Her responsibilities included research, assay development, and quality control. In 2000, she left her position as Director of QC at Chiron Technologies Center for Gene Therapy to start her own consulting business. For over 20 years, Ms. Sajjadi has provided services to biopharmaceutical companies, contract laboratories, non-profit organizations, universities and US government agencies. She has assisted clients in the development, implementation and improvement of quality programs for a range of cutting-edge products and provides technical expertise in assay development, qualification and validation. Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy and has served on 5 advisory panels for the United States Pharmacopeia (USP). She enjoys teaching introductory courses in bioassay design, development and validation for non-statisticians. Her company has recently expanded services to include leadership development and executive coaching to guide organizations toward sustaining a culture of quality.

Ralf Stegmann, PhD, Stegmann Systems GmbH