Lead Medical Advisor – Statistics Director

Dejun (DJ) Tang, PhD

Lead Medical Advisor & Director of Statistics

Dr. Dejun “DJ” Tang serves as Lead Medical Advisor at OncoFirm™ Diagnostics, bringing more than 27 years of pharmaceutical, healthcare, clinical development, medical-device, and biostatistical experience to the company’s diagnostic development programs.

Dr. Tang has held senior leadership positions across global pharmaceutical and clinical research organizations, including Novartis Pharmaceuticals, Sandoz, Firma Clinical Research, and Abbott Laboratories. His experience spans oncology, neuroscience, immunology, ophthalmology, biosimilars, diagnostic devices, and global clinical development.

Throughout his career, Dr. Tang has provided strategic leadership in clinical trial design, statistical methodology, regulatory submissions, clinical development planning, and interactions with international health authorities. He has led statistical and biometrics teams supporting NDA, BLA, supplemental NDA, and medical-device 510(k) submissions and has participated extensively in meetings and scientific consultations with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Japan’s PMDA, and Chinese regulatory authorities.

Earlier in his career at Abbott Laboratories, Dr. Tang served as lead statistician for more than 15 domestic and international diagnostic-device programs and contributed to more than 10 successful 510(k) regulatory submissions. His responsibilities included clinical study design, statistical strategy, sample-size determination, data analysis, regulatory documentation, and responses to FDA questions.

At OncoFirm™, Dr. Tang provides senior-level guidance supporting clinical development strategy, study design, validation planning, biostatistics, regulatory readiness, and evidence generation for the company’s developing diagnostic technologies. His expertise helps strengthen the scientific and clinical framework supporting OncoFirm’s mission to advance accessible, data-driven diagnostic technologies.

Dr. Tang earned his PhD and MS in Statistics from Purdue University, an MS in Mathematical Statistics from East China Normal University, and a BS in Mathematics from the Shanghai Institute of Education. He is also an accomplished scientific contributor, with numerous peer-reviewed publications and more than 50 presentations at international conferences and academic institutions.