Principal Scientist, Biostatistics, Late-Stage Clinical Development

Role: Lead biostatistician in the Late Development Statistics team within BARDS, overseeing statistical support for drug and vaccine projects, initially in specific disease areas such as oncology. Responsibilities: serve as statistical project leader, design and analyze clinical trials, coordinate with clinical, regulatory, and external partners, develop statistical plans, evaluate software and methodologies, interpret data, prepare regulatory submissions, and mentor junior staff. Requirements: PhD in statistics/biostatistics or related field with 6+ years (PhD) or 9+ years (Master’s) relevant experience; strong expertise in trial design, statistical analysis, and software (SAS/R); knowledge of worldwide regulatory requirements; excellent communication skills. Preferred: publications in peer-reviewed journals, understanding of biology/disease mechanisms, experience with regulatory interactions. High-Value: focus on clinical trials from Phase II to V, in medical drugs/vaccines, with a strong emphasis on regulatory compliance, statistical methodology, and cross-functional collaboration. Work setup: hybrid in the US with approximately 10% travel.