United States
• Hands-on experiences in study design and data analyses for phase I-III oncology clinical trials. • Successful NDA filing experiences for oncology new molecular entity. • Solid background in survival analysis, event projection, adaptive design, multiplicity, use of historical data, basket trial design, mixed effects model, etc. • Familiar with oncology therapeutic area including immuno-oncology (I-O) and related clinical endpoints. • Excellent problem-solving, critical-thinking, and task-prioritizing skills; demonstrated capability to work under stress. • Quick learner with the ability to drive innovative drug development strategies. • Exceptional communication and collaboration skills in a multi-disciplinary team. • Proficient with SAS, R, EAST, and Matlab.
• Program lead statistician for a new compound for rare endocrine disease. • Led all statistics activities for NDA and MAA submissions of the new compound under FDA priority review.
• Lead statistician for phase II pivotal breast cancer trial and phase II/III pivotal gastric cancer trial for Tukysa (tucatinib). • Supported NDA submission for Tukysa under Real-Time Oncology Review (RTOR); Tukysa was the first approved NME under Project Orbis. • Launched and led statistical methodology working groups.
• Trial statistician for multiple oncology phase I/II dose escalation and proof of concept trials and phase I clinical pharmacology trials. • Assisted in employee trainings in Bayesian design for oncology phase I trials and Pharmacokinetic study design
• Internship at Novartis Statistical Methodology and Consulting Group • Developed a drug-disease PK/PD model to predict the clinical response of an investigational drug vs. two competitors' drugs among diabetic macular edema (DME) patients and to inform phase III DME trial design.