Tanmay Khole

Background

About Tanmay Khole

Statistical Programming & Analytics leader with deep expertise in regulatory submissions process optimization and cross-functional team leadership. Skilled in developing scalable programming strategies driving data standardization and delivering high-quality outputs for global submissions across Oncology Neurology and Rare Disease programs. Known for strategic thinking and collaborative leadership that align programming execution with organizational goals. Committed to advancing analytics innovation shaping data-driven decision-making and influencing the future of drug development through impactful programming leadership. With a dual Master’s background in Statistics and Pharmaceutical Sciences I bring both technical expertise and therapeutic insight to every project. I've led cross-functional teams across global clinical trials (Phases II–IV) in oncology neurology hematology and rare diseases. My leadership style is rooted in collaboration mentorship and process innovation—ensuring timely compliant and impactful programming deliverables from study start-up through regulatory submission. I’ve built a track record of success at companies like Merck BMS/Celgene PTC Therapeutics and now Mural Oncology where I lead a growing team in driving programming strategy oversight of FSP partners and regulatory readiness. I'm also a dedicated contributor to the broader statistical programming community regularly presenting at industry conferences such as PharmaSUG and PhUSE. Let’s connect if you’re passionate about transforming data into clinical progress—or if you just want to chat about innovative approaches to statistical programming in clinical development.