• Authorline (AL): What was your motivation for writing your book?
• Brian Shilling (BS): Someone from SAS saw a presentation that Carol and I did together about validating clinical trial programming. It somehow got back to SAS Press and Judy Whatley approached us about writing a book on the topic. When we thought about it, we realized how many people we've spoken to who didn't have a clear understanding of what validation really involved and how to do it efficiently. After that, our motivation was to spread the word about how critical validation is to the clinical programming process and how to do it efficiently so there is time to do it right.
• (AL): Who are you targeting with your book?
• Carol Matthews (CM) and (BS): We're mainly targeting SAS programmers in the pharmaceutical industry. Our book focuses on clinical data and the validation required when working with these data. There are some advanced topics but for the most part it can be used by any level programmer in the industry.
• (AL): What features of the book are you especially pleased with?
• (CM) and (BS): We were most pleased with the breakdown of the different types of data and how validation is applied to each of those types. While some validation techniques are used for all different types of data, we have really made an effort to distinguish the key elements to look out for with different types of data. Really understanding the data and how to approach it can allow programmers to efficiently target their validation efforts, as well as make that validation more effective.
• (AL): How will your book benefit SAS users?
• (CM) and (BS): Validation has always been a critical part of the SAS programming effort for the analysis of clinical trial data. However, a clear-cut explanation and process for validation have never been fully defined or concisely presented. While we don't claim to have all of the answers, we have provided a comprehensive base for validation that can be used while building and implementing the validation process.
• (AL): How did you decide to coauthor the book? How did you divide your responsibilities?
• (CM) and (BS): Since our presentation was coauthored, it was easy to decide to coauthor the book. We have been colleagues for 11 years and have presented together as well as teaching sections on the applied use of SAS at the Philadelphia University SAS Certificate Course. We have a unique blend of style, which made the collaboration a simple decision. We divided the work based on each of our strengths and then reviewed each others' work.
• (AL): What did you learn while writing this book that would be important for other authors to know?
• (CM) and (BS): We learned that writing a book is a really involved and intricate task. Our biggest challenge was trying to write in a manner that sounded like one voice. When presenting and teaching, our individual technical strengths and presenting styles complement each other perfectly. When it came to the book, our individual writing styles are so different that the first drafts of the manuscript sounded very much like two different people. It was challenging to write as one unified voice, but with time and some help from one of our friends, we managed to do it.

  It was also challenging to include all of the data and programs that we used as examples. Since our day-to-day data is confidential, we had to create a lot of "dummy" data to be able to show output in the text.

• (AL): How did you decide to publish with SAS?
• (CM) and (BS): As we mentioned earlier, SAS approached us to write the book. Knowing many of the highly respected books that have been published by SAS, we were flattered to be asked to join the list of accomplished authors already represented by SAS. SAS made the process very easy for us and we are proud to be SAS Press authors.
• (AL): Your book will be going to the printer in just a few weeks. How does it feel to be in the home stretch of such a long project?
• (CM) and (BS): Excitement and a huge sense of accomplishment (relief?) are only just starting to sink in. The idea that this book is really done hasn't sunk in all of the way yet. Due to our type of business, working at different companies for some years and the challenges of everyday work life, the book has taken us about five years to complete. We don't think it will be a reality for us until we are holding printed copies!
• (AL): What advice would you give to potential authors?
• (CM) and (BS): Know that authoring a book is a big task. It is, though, a terrific opportunity to share your experience and knowledge, and to help other people with issues and concerns with which the potential author has dealt. It is a amazing how much you can learn about a topic you work with every day when you have to break it down to explain it to someone in written words. In a book, you have to be sure to give complete explanations and always keep your audience in mind; they aren't there in person to ask questions if you don't explain your point clearly and completely. In addition, working with SAS Press and all of the editors and contributors is absolutely wonderful. They all make it a very easy and painless process.
• (AL): How were you able to balance your time between your career and writing this book?
• (CM) and (BS): Trying to fit in writing this book with all of our work demands was really tough (one of the reasons it took us so long). There were whole months when we couldn't work on the book due to huge project demands on our time. Luckily, SAS was really understanding and patient with us and after a lot of nights and weekends spent writing, we finally finished. One thing that made it easier in the past few years was Brian joining Carol at UBC. This made things a lot easier as we could quickly and easily check with each other about content.
• (AL): When you aren't writing or working, how do you like to spend your free time?
• (BS): I must say in all honesty that I am a couch potato. After the stress of a work day, there is nothing like mindless television to let your mind wander. I have also increased my book reading lately. Gregory Maguire is my new favorite author as he writes novels around the stories I was told as a child.
• (CM): When we're not trying to keep up with two kids and all of their weekend activities, my husband, Cullen, and I love to travel and eat out at good restaurants whenever we get the chance. I also have two horses that I try to ride as much as possible; trail riding through the woods is the best way to clear my head after a hectic work day.

Brian C. Shilling is Senior Manager of Clinical Programming at United BioSource Corporation (UBC), where he manages a team of SAS programmers. He has over two decades of experience in the pharmaceutical industry and is a chair emeritus of the Pharmaceutical Industry SAS Users Group (PharmaSUG). Brian is an adjunct faculty member at Philadelphia University and Arcadia University in Philadelphia, PA.

The authors also teach the "SAS Programming Certificate for the Pharmaceutical Industry" course for Philadelphia University's continuing education program. The program addresses good programming practices, common clinical data sets, reporting with data _null, and SAS macros.