Elisa Young

How long have you been volunteering at CDISC?

I had considered volunteering with CDISC for years, and finally took the plunge last year. I have been volunteering with CDISC now for five months.

What encouraged you to volunteer your time and expertise with CDISC?

I obtained my CDISC Tabulation Certification last year as part of the pilot program, which gave me the confidence to know I could make a valuable contribution to the CDISC Community. When I saw the volunteer call for the CORE project, I registered my interest straight away. I already had a particular interest in the programming of CDISC Conformance Rules and I knew this would be a great opportunity to put my SDTM knowledge to good use.

How did you begin working in clinical research?

I worked as a laboratory scientist at the same time as completing my PhD in Pharmacology. After making the decision to move from academia to industry, I landed a position as the Laboratory Manager at Leica Biosystems. I found that I particularly enjoyed two aspects of the job, the project management and the data management. I then went on a two-career trajectory, taking a position as an Associate Project Manager at Hospira whilst undertaking my Master of Applied Statistics. In the final year of my Master’s I took a position as a joint Project Manager/Statistician at the Royal Women’s Hospital, which allowed me to put my statistics and programming to practical use. Completing my Master is what, in 2013, finally opened the door to my career in clinical research statistics and statistical programming.

Over the last nine years I’ve built up my biostatistics and statistical programming skills, with a (some would say obsessive) focus on CDISC, which has led to my current position at Accelagen, an Australian CRO, where I will be leading the development of a statistics and statistical programming department from inception.

What did you want to be when you grew up?

I always knew I’d be happiest somewhere in the Science realm. I didn’t even know about the world of clinical research until I went to university, but after a work placement year in the field, my career goals were set.

Your volunteer contribution is unique at CDISC with regard to where you work (Australia) as well as what you're working on. Could you share your insights on: 1) working in a time zone that is generally opposite other CDISC volunteers and 2) what it's been like being at the forefront of a new CDISC initiative (machine-readable Conformance Rules)?

Initially, I did have concerns around the time-zone difference that would prevent me from being able to attend all the weekly calls; I don’t mind the odd 1am call, but the 3am phone calls (thank you daylight savings!) are not feasible. I needn’t have worried. The project leads have done a fabulous job of keeping the team informed with meeting agendas, recorded meetings for team members who couldn’t attend to watch later, and an extensive wiki set up. The use of JIRA to raise and track all the issues has also been a great tool to communicate about specific issues/questions and works seamlessly with the Wiki.

The CORE project is such an ambitious and exciting initiative. It is an absolute privilege to be part of the CORE initiative team. There are so many challenges, technically, logically and practically. It really makes one appreciate the nuances of the standards and the way in which Conformance Rules need to be applied. It’s also a particularly good initiative for someone who is on the other side of the world, as much of the work is in the programming and testing of the Conformance Rules, which is done at one’s own pace.

Please provide a tip that someone would find helpful in working with CDISC Standards.

Keeping on top of all the changes happening with regards to the CDISC standards, regulatory guidances, PHUSE whitepaper releases, etc., can be onerous. My tip is to take 30 minutes to identify the various organisations and agencies important to your work and find a way to automate your following of their activities, whether it be by registering your email address on their website to receive updates, signing up to their RSS feed or following them on LinkedIn and Twitter.