Todd Case
Senior Director, Vertex Pharmaceuticals
Todd Case has been working in the pharmaceutical industry as a statistical programmer for over 20 years. He completed his Master of Science in Epidemiology from Columbia University and has worked at Forest Laboratories (now Allergan), Genentech, Bristol-Myers Squibb, and Biogen. He currently works at Vertex Pharmaceuticals, where he is a Senior Director in the Biometrics department. Todd has published a number of papers related to clinical data standards, management and leadership, and statistical programming using SAS/R/Python. He is also a frequent speaker, presenter, and panelist at conferences in the US and internationally, including the European Medicines Agency (EMA), PhUSE, PharmaSUG, NESUG, SAS Global Forum, Joint Statistical Meetings (JSM), the Women's Innovation Network, and the University of Connecticut. He has won “Best Paper” awards in both the Standards and ePoster sessions of PharmaSUG.
In his spare time, Todd loves to read (and write), travel with his family, and enjoy time outdoors including running 20 marathons in 19 states as of this publishing.
By This Author
An Introduction to Creating Standardized Clinical Trial Data with SAS®
By Todd Case and YuTing Tian
An indispensable guide for statistical programmers in the pharmaceutical industry.
Statistical programmers in the pharmaceutical industry need to create standardized clinical data using rules created and governed by the Clinical Data Interchange Standards Consortium (CDISC). This book introduces the basic concepts, pharmaceutical industry knowledge, and SAS programming practices that every programmer needs to know to comply with regulatory requirements. Step-by-step, you will learn how data should be structured at each stage of the process from annotating electronic Case Report Forms (eCRFs) and defining the relationship between SDTM and ADaM, to understanding how to generate a Define-XML file to transmit metadata. Filled with clear explanations and example code, this book focuses only on the essential information that entry-level programmers need to succeed.
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"An Introduction to Creating Standardized Clinical Trial Data with SAS is a new book designed to give programmers a jump start into the regulatory requirements of the pharmaceutical industry. This unique book goes behind the scenes to better explain the mechanics of SDTMs and ADaMs."
Sunil Gupta
SAS/CDISC Consultant, Trainer and Author
Featured Authors
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Todd Case has been working in the pharmaceutical industry as a statistical programmer for over 20 years. He completed his MS in Epidemiology from Columbia University and has worked at Forest Laboratories (now Allergan), Genentech, Bristol-Myers Squibb, and Biogen. He currently works at Vertex Pharmaceuticals.
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Terisa Roberts is a director and Global Solution lead for Risk Modeling and Decisioning at SAS. She has extensive experience in quantitative risk management, regulatory compliance, and model governance and validation. She has worked in financial services, telecommunications, government, energy, and retail sectors.
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Robert N. Rodriguez retired from SAS in 2018 after serving as a senior director in research and development. Bob received a PhD in statistics from the University of North Carolina at Chapel Hill and was a research statistician at General Motors Research Laboratories before joining SAS.
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Ron Klimberg, PhD, is a professor at the Haub School of Business at Saint Joseph's University in Philadelphia, PA.