David Neubauer

David Neubauer

Standards Engineer


How long have you been volunteering at CDISC? 

I have been volunteering with CDISC for just over 6 years now. Active: 6+ years on SDS Oncology, 4 ½ years SDS Team, 3 years co-leading SUPPtoNSV. Previously SDS MSG 2.0.

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

I learned of CDISC’s mission and SDTM standards, beginning with SDTMIG 3.1.1 in late 2007, and have been a fan of and advocate for them ever since. While reading, being trained on, and implementing the standards on NDAs, this really became an area that I felt I could focus my skills in helping organizations adopt the use of the standards. Even with SDTMIG 3.1.1, it seemed like with CDISC standards, a lot of the work was done for industry and there was a common language to communicate with different organizations and within data management and biostatistics/programming. It wasn’t until after I had been implementing CDISC standards for about 8 years, and to much success, that my manager requested that I look for volunteer opportunities within CDISC. Since then, it’s been wonderful to team and grow professionally with amazing individuals across a wide range of backgrounds, skill sets, and organizations. I feel as though I’ve made meaningful contributions to the teams I’ve worked with, and I’ve learned so much from each team member and effort in developing standards. 

How did you begin working in clinical research? 

My very first clinical research job was effectively temp to hire data entry for a few weeks which quickly ramped up to reading the FDA CFR and writing SOPs for CRO/Sponsor and helping with IDEs and device studies.

What did you want to be when you grew up? 

A veterinarian or an artist. I’ve always loved animals, playing music (drums), writing, drawing, etc. Instead of a veterinarian or an artist, I’m delighted to be a father whose daughter shares those loves. 

You are working on the next release of the SDTMIG, version 4.0. What are you excited about with this release and what updates do you think the user community will find most useful?

I’m really excited about all the amazing work the SDS SUPPtoNSV sub-team has been putting forth in the SDTMIG 4.0 with the change from Supplemental Qualifiers to the alternative representation of Non-Standard Variables (NS--). NS-- simplifies how NSVs can be split/merged outside of a submission and allow for more robust variable level metadata. The SDS team has done exceptional work resolving older issues, making substantive improvements to variable level metadata and definitions, and developing new domains (no spoilers). SDTMIG 4.0 will be a major achievement for the team and benefit for our industry.

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

I suggest filling out that volunteer form and getting involved. Hearing others’ experiences and opinions and sharing your own is invaluable. Your participation will greatly benefit yourself, your organization, as well as CDISC and others.