Masna Rai

WORK HISTORY

EDUCATION

ABOUT MASNA RAI

7 years of experience in Biostatistics. Currently, biostatistics lead for pivotal trials for Biosimilars, which include first-in-human (Phase I) Pharmacokinetic as well as clinical efficacy (Phase trials. I design statistical sections of the clinical trail protocol, oversee all statistical activities, and ensure the quality of the deliverables for regulatory submissions (FDA, EMA, PMDA, Health Canada). During the study design phase, I am actively involved in interactions with the health authorities seeking endorsement for proposed statistical approaches, sample size, and statistical models. I have a previous 5 years of research experience with real world evidence (RWE). During this time, I worked with different institutions across the EU as well as in the US. This multi-country and inter-disciplinary collaborations adds to my deep understanding of the RWD, expertise in RWD analysis, hypothesis testing, and successfully seeking RWE. During this time, I have developed models, which based on present-day evidence and using simulation techniques, is able to project specific clinical outcomes in the future. Efficient team player | Effective communicator | Strategic planner | Creative problem solver