This document is a cover letter from Katherine Nicholas, a PhD candidate in Biostatistics at the Medical University of South Carolina, defending her dissertation on March 21, 2016 about covariate adjustment in non-inferiority clinical trials. Her work addresses how failing to adjust for important prognostic factors can impact type I error, and she has developed new methodology for choosing covariates. She has had enriching research experiences serving as a statistical analyst and collaborating on multicenter clinical trials. She is seeking a position where she can be an independent researcher, cultivate new collaborations, and mentor others.

1. March 15th, 2016
To whom it may concern:
I am currently a PhD candidate in Biostatistics at the Medical University of South
Carolina (MUSC), Department of Public Health Sciences and will defend my dissertation March
21, 2016. My methodological work is in covariate adjustment in non-inferiority clinical trials
and its implications for type I error. My collaborative work has been in neurological
emergencies, organ transplant, and behavioral sciences.
My dissertation addresses the issue of covariate adjustment in non-inferiority trials and
evaluates the impact on type I error due to failing to adjust for important prognostic factors. I
have also developed new methodology for choosing covariates for adjustment based on disparity
with treatment allocation and influence on outcome. This method can be used when prognostic
factors are not known in advance. The first paper of my dissertation has been published in
Statistics in Medicine (Nicholas et al. 2015).
I have had several enriching research experiences while at MUSC including serving as a
statistical and research analyst for substance abuse research in the Department of Psychiatry,
Clinical Neuroscience Division and collaborating with the Data Coordination Unit in the
Department of Public Health Sciences on several multicenter clinical trials with a particular
focus in neurological emergencies. Through these projects, I was afforded the opportunity to use
a wide variety of analytical methods including repeated measures analysis, multilevel data
analysis, non-parametric methods, and epidemiological methodology. By working closely with
my mentor, Dr. Valerie Durkalski, I was able to learn a great deal about the design and conduct
of clinical trials and receive hands on experience with a specific trial in status epilepticus that
was the motivation for my dissertation research and led to several collaborative publications as
seen in my CV.
During my PhD program, the experiences and interactions with my professors and
clinical collaborators have helped me to develop a comprehensive approach to the conduct of
clinical research, which I feel would make me an effective member of your team (engaging in
methodological and collaborative work, mentoring, and effectively communicating with
individuals across disciplines). As I move into the next phase of my career, I would like to be in
an environment conducive to being an independent researcher and mentor, cultivating new
collaborations, and extending my focus to new clinical areas.
I have submitted a copy of my curriculum vitae for your review. If you have any questions or
require any additional information, please contact me via email at nicholk@musc.edu or on my
cell phone at (901)517-7406. Thank you for your consideration.
Sincerely,
KSNicholas
Katherine Nicholas