Luis Rojas, PhD, MSc
Dr. Luis Rojas is a senior clinical development strategist, research scientist, and biostatistician with more than 30 years of experience across pharmaceutical, biotechnology, CRO, academic, and medical-device organizations. He leads InCSD’s scientific and consulting strategy and remains directly engaged in complex development decisions and technical work.
His work connects clinical development and regulatory strategy with biostatistics, pharmacometrics, clinical operations, CMC considerations, and commercial and portfolio decision-making. He supports sponsors from early development and dose strategy through confirmatory planning, evidence generation, regulatory interactions, and partner readiness.
Areas of Expertise
Professional Experience & Contributions
His experience includes leadership and senior scientific roles at InCSD, Indication BioScience, the Curyx Bio platform, dMed Clinipace, Target Health, Parexel, and IQVIA, with earlier research and industry experience. His work spans rare diseases, oncology, neurology, cardiometabolic disease, immunology, infectious diseases, and other therapeutic areas.
He has developed clinical protocols, statistical analysis strategies, simulation frameworks, natural-history and external-evidence approaches, and quantitative evidence packages supporting clinical development and regulatory planning. He also supports asset due diligence, portfolio decisions, scientific communications, and commercial or partnering readiness.
Dr. Rojas developed the Mechanistic Endpoint Definition (MED) methodological framework and has presented on clinical research methods and development strategy at industry conferences, including rare-disease and international partnering events.
Education & Credentials
PhD in Statistics, Rafael Belloso Chacín University, Venezuela. Completed pharmaceutical regulatory affairs training through the Regulatory Affairs Professionals Society (RAPS), covering United States, European Union, and global regulatory frameworks. Professional affiliations have included the American Statistical Association, Sigma Xi, the DIA Adaptive Design Scientific Working Group, and RAPS.
