Staff Biostatistician

Job Summary

To support the development of clinical-stage therapeutic assets, the full-time remote Staff Biostatistician will serve as the senior technical authority on statistics, leading trial design, conducting high-stakes analyses, and representing statistical findings to regulators.

Key responsibilities

• Lead statistical assessments on asset acquisitions, providing final verdicts that inform decisions
• Set standards for trial design, overseeing the development of complex trials and reviewing others' designs
• Own interim and final analyses with significant consequences, serving as the senior statistical authority in regulatory interactions

Required qualifications

• PhD or Master's in Biostatistics, Statistics, or a related field with 9+ years of experience in clinical biostatistics
• Experience preparing statistical content for FDA submissions (IND, NDA, or BLA)
• Proficiency in leading statistical strategy across multiple trials, including complex or adaptive designs
• Fluency in R or SAS, with experience directing programming work
• Demonstrated ability to represent statistical positions directly to regulators