Tuesday, June 25 • 4:15pm - 5:30pm
#298: Clinical Safety Assessment: What’s a Statistician Got to Do with It?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-637-L04-P; CME 1.25; IACET 1.25; RN 1.25

Statistical attention to safety data is often times left to routine, basic calculations and tabulations. Absent statistical input, the data run the risk of being presented in ways that are unintuitive, uninformative, or in the worst case, deceptive. Speakers in this session will present examples where statisticians are collaborating with clinical colleagues and data scientists to more effectively analyze and clinically interpret safety data.

Learning Objectives

Recognize the importance of statistical engagement in the assessment of clinical trial safety data; Apply appropriate statistical methods in the analysis of safety data; Identify the need to work collaboratively with clinicians and data scientists.


Mat Soukup, PhD


Improving Analyses and Displays for Clinical Trial Safety Data
Mary Nilsson, MS

ASA/DIA Safety WG Presents: Finding Safety Signals During Clinical Development with R Shiny
Susan Duke, MSc

FDA Perspective
Matthew Guerra, PhD

avatar for Susan Duke

Susan Duke

Mathematical Statistician, OB, OTS, CDER, FDA
Susan became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG. She is currently a Mathematical Statistician reviewer in CDER and member of a cross-functional safety monitoring WG co-sponsored by DIA and ASA Biopharm... Read More →

Matthew Guerra

Mathematical Statistician, OB, OTS, CDER, FDA
Matthew is a senior statistical reviewer supporting the Division of Dermatology and Dental Products (DDDP) in the Center for Drug Evaluation and Research (CDER) at the FDA. Matthew joined the FDA in 2011 immediately after receiving his Ph.D. in Biostatistics from the University of... Read More →
avatar for Mary Nilsson

Mary Nilsson

Statistician, Eli Lilly and Company
Mary received a MS degree in statistics from Iowa State University in 1989. She has been employed at Lilly since 1989 and is currently a research advisor in the Safety Analytics group within the Statistical Sciences function. She consults with compound teams on safety analysis planning... Read More →

Mat Soukup

Deputy Div. Director, Div. of Biometrics VII, Office of Biostatistics, OTS CDER, FDA
Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team... Read More →

Tuesday June 25, 2019 4:15pm - 5:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session