Todd Case, YuTing Tian

eBook, ePUB

An Introduction to Creating Standardized Clinical Trial Data with SAS (eBook, ePUB)

Beschreibung

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.

Technische Details

• Geräte: eReader
• mit Kopierschutz
• Größe: 8.65MB

Barrierefreiheit

• Text-to-Speech

Autor

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.

Produktdetails

• Verlag: SAS Institute
• Seitenzahl: 238
• Erscheinungstermin: 17. August 2022
• Englisch
• ISBN-13: 9781955977975
• Artikelnr.: 65266897