The Statisticians
We are a team trained in statistical methodology and skilled in statistical programming, including SAS, R, Power Analysis Statistical Software (PASS), Excel, Minitab, SPSS, and others.
Principal Statistician and President – Colleen Kelly, Ph.D
Dr. Colleen Kelly is an Accredited Professional Statistician™ and has over 30 years of statistical consulting experience as a statistical consultant, professor, and researcher specializing in statistical methodology for clinical trials, epidemiological studies, molecular evolution and other biological studies. She holds a Ph.D. from the University of California, San Diego. She has designed studies, analyzed data, written statistical analysis plans and reports in the oncology, pharmaceutical, vaccine and medical device arenas.
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She has experience with 510K and NDA submissions to the FDA. At Exponent, she teamed with engineers to design quality control processes and conduct failure analyses and reliability studies of medical devices and mechanical products. At Moores Cancer Center, she teamed with cancer researchers to design sound and efficient clinical trials and animal studies. She has served as the lead statistician on several NIH and NSF grants. Additionally, she has served as an expert witness in civil cases involving construction defects, medical devices, intellectual property, antitrust and employee compensation.
As a tenured associate professor of statistics at San Diego State University, Dr. Kelly co-founded and co-directed the university’s statistical consulting center. At Victoria University in Wellington, New Zealand, she directed the university’s statistical consulting center, providing advice and data analysis for university researchers and the Ministry of Health.
Dr. Kelly’s research is primarily focused in biostatistics, developing statistical methodology to address biological and medical problems. She has developed and evaluated methodology for identifying drug interactions, and analyzing data from clinical trials and epidemiological, ecological, and behavioral studies. She has also worked in the area of modeling molecular evolution.
Project Manager, Diana Le, M.S.
Diana Le is a seasoned statistical analyst and programmer with over 8 years of industry experience in the medical device and pharmaceutical fields. Diana serves as the managing statistician, responsible for managing and guiding projects in clinical trials and experimental studies. She has played a key role in supporting the approval of FDA submissions, as well as in drafting statistical analysis plans and completing clinical statistical reports. Diana’s expertise encompasses a wide range of biostatistical methods, including logistic regression, mixed-effects repeated measures models, and survival analysis. Additionally, Diana has experience working with CDISC standards, particularly SDTM and ADaM.
Diana holds a B.S. in Applied Mathematics and an M.S. in Statistics.
Statistical Associate, Sarah Blatt, M.S.
Sarah holds both a B.S. and M.S. in Statistics from San Diego State University. She joined the Kelly Statistical Consulting team in January of 2019, shortly before finishing her undergraduate studies. Her main responsibilities at KSC include building and managing datasets, and producing statistical tables, charts, and listings in SAS.
Sarah previously worked at A4D Marketing in Carlsbad, CA where she was in charge of modeling advertisement performance and advising budget allocation. In her free time, she enjoys reading, cooking, snowboarding, and raising her cat Nutmeg.
Statistical Associate, Amy Zimmer, M.S.
Amy has a bachelor’s degree in the Biological Sciences from the University of California, Santa Barbara and a master’s degree in Statistics from San Diego State University. Amy taught Statistics, Mathematics and Biology for 23 years at the college, high school and middle school levels. At San Diego State University, she was a statistics lecturer and a co-coordinator of the master’s teaching program. Amy also has experience as a Criminalist for the San Diego Police Department Crime Laboratory in the Forensic Chemistry Unit analyzing impounded evidence, providing expert testimony, developing the uncertainty of measurement methods for instruments and reconstructing crime scenes based on blood spatter evidence and bullet trajectories. She has expertise in general statistical methodology, analysis, experimental design and report writing.
Statistical Assistant, Savanna Spayd
Savanna Spayd is a motivated and eager Statistical Programmer in her final year of studying Statistics and Computer Science at San Diego State University. She is a talented programmer in SAS and Java languages and is gaining experience in other languages such as R, Python, and C++. She joined KSC in October of 2022 and is excited to start her career in the field and gain hands-on experience.
Statistical Associate, Xianwen Cao, M.S.
Xianwen Cao is an experienced statistical analyst and programmer for clinical trials. She works in the medical device, diagnostics and pharmaceutical industries. She has served as the lead programmer, producing reusable SAS Macros, Tables, Listings and Figures supporting FDA submissions. As a statistical consultant, Xianwen Cao assists oncology studies for efficacy evaluation and Patient-Reported-Outcome data analyses. She handles biostatistical analyses including power analyses and sample size calculations, logistic regression, mixed-effects repeated-measurement models, and survival analysis. Her other responsibilities include reviewing statistical analysis plans and clinical study reports.
Xianwen Cao holds a M.S. in Statistics and a M.S. in Pharmacy. Before joining Kelly Statistical Consulting, Xianwen Cao worked in the drug discovery and development industry. She has a two-year-old ragdoll cat named Cream.
Statistical Associate, David Tu
David has a bachelor’s degree in Mathematical Statistics from the University of California – San Diego and is a current graduate student at San Diego State University pursuing a master’s degree in Statistics. He has experience coding in Python, R, and SAS. David joined Kelly Statistical Consulting in May of 2023. Before joining, David primarily worked in education as a tutor and facilitator for high school students and a teaching assistant in Mathematics and Statistics at both UCSD and SDSU.
