Synopsis
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.
About the Authors
YuTing Tian completed her Master of Science in Statistics and works for Vertex Pharmaceuticals as a statistical programmer. She has published a number of papers related to artificial Intelligence, statistical analysis, and statistical programming with SAS/R/Python. These are mostly derived from papers that she presented at conferences including SAS Global Forum and Joint Statistical Meetings (JSM). One of her papers, presented at PharmaSUG, was awarded “Best Paper” in the ePoster session. She won first place for public speech in the international Toastmaster competition, Area 33 (Cambridge, MA). YuTing is a native of China and has been living in the US for almost five years. She has been perfecting her skills playing the violin and taking lessons to be licensed as a private pilot. She has a license to drive engine-driven boats and in 2022 won two team silver medals with Pentasus in the Boston Hong Kong Dragon Boat races.
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 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.
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