Workshop: Biostatistics for Beginners

Tuesday, October 15, 2019 | 9:30 am – 5:30 pm

Instructor:

Nancy Sajjadi, MSc, Independent Quality Consultant

ABOUT THIS WORKSHOP:

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.

TOPICS TO BE COVERED INCLUDE:

• The Role of Statistics in 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
• The meaning of r2
• Log transformation
• Interpreting Assay Validation Guidance
• USP Metrics for Evaluating Assay Precision

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 it to Kaitlyn Barago, Workshop Organizer.

WORKSHOP AGENDA

9:30 am Start of Workshop

11:10 Networking Coffee Break

1:00 pm Enjoy Lunch on Your Own

2:15 Workshop Resumes

4:00 Networking Refreshment Break

5:30 Close of Workshop

WHO SHOULD ATTEND

• 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

INSTRUCTOR BIOGRAPHY:

Nancy Sajjadi, M.Sc. is an independent quality consultant with over 30 years of experience in biopharmaceutical product development.  She began her career as a bench scientist at a small cell and gene therapy company developing retroviral vectors for infectious disease, cancer and cell therapy applications.  Her responsibilities included research, development, and quality control. Five years after the company was acquired, she left her position as Director of QC at Chiron Technologies Center for Gene Therapy to start a consulting business. 

Over the last 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 biopharmaceutical products in early phase development.  She also has provided technical expertise in assay development, qualification and validation.  Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy, has served on 5 advisory panels for the United States Pharmacopeia (USP) and teaches introductory courses in bioassay design, development, validation and fundamental concepts in biostatistics for non-statisticians.

*Separate registration required.