Karen Wade, M.S., has more than 20 years of experience providing statistical support for clinical trials and regulatory submissions and is an expert on CDISC implementation and standards. Her work has included serving as lead statistician to complete displays and datasets for many ISS/ISEs (as well as the associated pivotal studies). In addition to serving as a statistical lead for submission projects, Karen has taken a lead role in managing many Phase 1 through Phase 3 SDTM/ADaM dataset conversion projects across a variety of therapeutic areas. Ms. Wade is skilled in writing detailed statistical analysis plans, conducting statistical programming and analysis of clinical data, and writing and reviewing statistical reports. Ms. Wade has significant experience preparing statistical analysis specifications of analysis databases, summary tables, listings, and graphical displays.

Why Clinical Research?

“I was drawn to the field of clinical research due to the opportunity to learn about a vast variety of medical conditions and diseases. I learn something new every day which makes my job exciting and rewarding. I am driven by the knowledge that the work I do impacts lives. My goal as a statistician is to provide the highest quality data so that researchers and regulatory agencies can make the most informed decision possible about a potential treatment. For me, working with data is like putting together a puzzle, which is also a passion of mine.”