Retired Statistical Programmer
How long have you been volunteering at CDISC?
Since May of 2006
What encouraged you to volunteer your time and expertise with CDISC?
I met Frank Newby at a meeting and he said that CDISC would be starting a medical device team. He got my contact information and several months later he invited me to join a team for medical devices. Our first team meeting was in May of 2006.
How did you begin working in clinical research?
I have a master's degree in epidemiology and started working as an epidemiolgist in 1983. I then became interested in clinincal trials and worked for two years as a study coordinator starting in 1994. I then got my first job in pharma in 1996. Since 1996, I have worked as a SAS statistical programmer for pharma and medical device companies. I just retired this month.
What did you want to be when you grew up?
Originally, I wanted to be a medical doctor. But I loved baseball and became interested in statistics. But it took me a while in college and grad school to figure out my career path.
CDISC Standards are not required for medical device submissions to the US FDA. Can you tell us why it’s a good idea to use them anyway?
Standards are good for companies, not just for submissions. Does that mean that device companies need to follow CDISC standards instead of internal company standards? No. But CDISC provides standards for many types of data collected by medical device companies. So, medical device companies do not need to reinvent the wheel if they use CDISC standards. Also, if medical devce companies do combintion drug/device products, it will make the review easier if the medical device company follows CDISC standards. But the main motivation for a medical device company to follow CDISC standards would be to make their own processes more efficient.
Please provide a tip that someone would find helpful in working with CDISC Standards.
Don't be afraid of asking questions of the FDA regarding CDISC standards. I have found it especially helpful for Regulatory Affairs to use Type C (written questions and responses) to ask the FDA specific questions about implementing CDISC standards for submissions.