David Raunig, PhD

David Raunig, PhD, is a Senior Partner at The Bracken Group and a statistician whose career sits where biostatistics, medical imaging, and drug development meet. Over three decades he has guided programs from Phase 0 through Phase III and post-approval, writing the statistical and biomarker analysis plans behind FDA and EMA submissions, contributing to the development of five FDA-validated study biomarkers, and leading disease progression modeling in oncology, neurodegeneration, and GI transit.

Before Bracken, he headed Oncology Translational Statistics at Takeda, served as Vice President of Medical, Scientific and Statistical Affairs at ICON Clinical Research, and spent 15 years at Pfizer, where he built a Statistical Image Analysis Network to support medical imaging in oncology clinical trials. He has co-chaired the Biomarker Qualification Statistics Expert Team and the Quantitative Imaging Biomarkers Alliance’s Technical Performance Metrology group, and has published widely on multiparametric imaging biomarkers and independent reader performance.

At Bracken, David is lead statistician on radiopharmaceutical programs, including a cardiac perfusion imaging study and oncology diagnostic agent development in two indications. He began his career as a submarine officer in the U.S. Navy after graduating from the U.S. Naval Academy, then spent a decade as a lead scientist in the defense industry, where his validation work on the Trident program was commended by the Secretary of Defense.