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11: Statistics [clear filter]
Monday, June 24


#101 CH: Modernizing Data Review in Drug Development with R Shiny
Component Type: Workshop
Level: Intermediate

ASA Biopharm/DIA Safety Working Group, safety clinicians, statisticians and data scientists, developed an R Shiny tool available for all, initially for detection and review of hepatotoxicity. Discuss this new tool and seek input on next steps and support.

Learning Objectives

Describe an R Shiny safety tool developed by the Interactive Safety Graphics taskforce of the ASA Biopharm/DIA Safety Working Group, for review of liver function and Hy’s Law for use during drug development and submission review; Discuss audience feedback on path forward for this new model of agile software development and support, with consideration of compliance.


Susan Duke, MSc

avatar for Susan Duke

Susan Duke

Mathematical Statistician, OB, OTS, CDER, FDA
Susanis is a Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. She became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG, which lead to subsequent interests... Read More →

Monday June 24, 2019 10:10am - 10:40am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
Tuesday, June 25


#221 CH: Getting the Question Right (GTQR) with Interdisciplinary Collaboration
Component Type: Workshop
Level: Intermediate

Inspired by the E9 R1 estimand framework, the DIA Getting the Question Right (GTQR) webinar series was organized in 2018 via intercommunity collaboration. This hub will provide a synthetic overview of the 6 popular webinars, followed by open Q&As.

Learning Objectives

Discuss the estimand framework described in the draft ICH E9 addendum; Recognize how the estimand framework may help get the question right and can be applied in various therapeutic and safety/benefit-risk contexts; Define how the estimand framework may advance the interpretation of study results.


William Wang, PhD

avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →

Tuesday June 25, 2019 9:15am - 9:45am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
Wednesday, June 26


#394: Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-710-L04-P; CME 1.25; IACET 1.25; RN 1.25

Not a statistician? Then this workshop is for you!

Group activities and slide-based learning will be used to introduce commonly used statistical concepts using real clinical trial results from publicly posted FDA reviews.

Learning Objectives

Explain basic statistical concepts such as randomization, blinding, hypothesis testing, p-values, the challenges of false positives and adjusting for multiplicity, and approaches to handling missing data; Identify the appropriate statistical analysis for a given outcome; Discuss assumptions and limitations of analysis methods with a study team; Assess the clinical importance of statistical results.


Matt Baldwin, MS


Stephen Corson, PhD

Munish Mehra

avatar for Matt Baldwin

Matt Baldwin

Senior Biostatistician, Advance Research Associates, Inc (ARA)
Matt Baldwin is a Senior Biostatistician who works with Advance Research Associates to advance clinical solutions through analysis. Matt’s various positions have provided experience in randomization, generic and new drugs, statistical clinical development, DMC support, and analysis... Read More →
avatar for Stephen Corson

Stephen Corson

Senior Statistician II, Phastar
I am a Senior Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA