Luis Rojas | CEO and President
INCSD LLC

Dr. Luis A. Rojas is a clinical development and biostatistics leader with extensive experience supporting Phase I–IV programs across drugs, biologics, and medical devices. He combines executive leadership with deep technical expertise, actively contributing to clinical strategy, study design, protocol and Statistical Analysis Plan development, modeling and simulation, and regulatory interactions. His work is characterized by the integration of clinical, statistical, and operational components to support efficient and regulatory-aligned program advancement. He currently serves as CEO of InCSD and Chief Clinical Development Officer at Indication Bioscience, where he leads clinical development strategy, biometrics, and regulatory activities across programs. His responsibilities include defining endpoints and estimands, overseeing statistical strategy, and leading the preparation of regulatory submissions and interactions. Throughout his career, he has held senior leadership roles at global organizations including IQVIA, PAREXEL, and D-Med Clinipace, providing advanced statistical and clinical development expertise across multiple therapeutic areas. Dr. Rojas has significant experience in adaptive and complex trial designs, rare disease development, and simulation-based methodologies. He has contributed to the design and execution of innovative clinical programs and has led statistical strategy for key regulatory milestones, including IND and late-phase submissions. He is also the developer of the Mechanistic Endpoint Definition (MED) framework, a methodological approach aimed at improving the alignment between clinical objectives, endpoints, and statistical inference in clinical trials