I’m a biostatistician with more than a decade of experience supporting clinical, non‑clinical, and real‑world evidence studies across drugs, medical devices, and biologics. My work blends rigorous statistical training with hands‑on leadership across the full biometrics spectrum.

My academic foundation includes a Bachelor’s degree in Applied Mathematical Economics from Marquette University (summa cum laude) with minors in Biology and Business Administration, followed by a Master’s degree in Statistics from the University of Wisconsin–Madison.

I began my career in real‑world evidence, performing statistical analyses using registry data for peer‑reviewed publications, collaborating closely with clinicians and researchers. I later moved into industry, spending nine years progressing from Lead Statistician to Head of Statistics, Data Management, and Statistical Programming. In that role, I oversaw our global biometrics activities across all phases of clinical development.

In addition to my clinical work, I bring experience in CMC and non‑clinical statistics, including process capability analysis, stability studies, and in vitro bioequivalence testing. This combination of clinical and non‑clinical expertise allows me to support programs from early development through commercialization with a consistent, statistically sound approach.

My background includes:

• Study design and statistical strategy for clinical and real-world evidence studies

• SAP and TLF shell development

• Data management planning, CRF design, and database review

• Oversight of CDISC SDTM, ADaM, and TLF development

• Representing biometrics in audits and regulatory authority meetings and responses (including FDA, EMA, PMDA, TUV, and many others)

• Developing fit‑for‑purpose, risk‑based SOPs and templates

• Building and managing biometrics teams across in‑house, FSP, outsourced, and hybrid models

• Creating training programs for statisticians and data managers

• Supporting due diligence for potential acquisitions

• Statistical support for manufacturing, quality, and analytical method development

Across all of these roles, my focus has remained the same: deliver high‑quality, defensible results while making complex statistical concepts clear and accessible. Today, I bring that same commitment to my consulting practice, helping life‑science teams generate reliable evidence and make confident, data‑driven decisions.