Principal Scientist, Biostatistics, Late-Stage Clinical Development

Role: Principal Biostatistician supporting late-phase clinical trials within a leading biopharma R&D division, focusing on drug and vaccine development. Responsibilities: develop and oversee statistical support for clinical programs, lead trial design and analysis, coordinate data management and programming activities, and ensure regulatory compliance. Lead a team of statisticians or programmers, collaborate with Medical, Data, Research, and Regulatory teams, prepare reports for regulatory submissions, and contribute to scientific publications. Conduct research on new statistical methodologies and provide training. Qualifications: Ph.D. (preferred) or MS in Biostatistics/Statistics, with at least 6 years (Ph.D.) or 9 years (MS) relevant industry experience; strong expertise in clinical trial design, analysis, regulatory submission, and statistical programming. High-Value: extensive experience in late-stage (Ph II/III) clinical trials, regulatory interactions, and drug/vaccine development, especially in immunology or respiratory areas. Work setup: hybrid model; approximately 10% travel.