Director, Biostatistics

Role: Lead biostatistics for late-phase (Phase 2/3) clinical development programs, focusing on designing innovative trials, authoring statistical protocols, and supporting regulatory submissions. Responsibilities include strategic input to Clinical Development Plans, collaboration with cross-functional teams to design trials and data collection tools, statistical analysis, interpretation, and communication of results for regulatory and scientific purposes. The role also involves leading statistical support for global regulatory interactions and contributing to regulatory documents like study reports and briefing documents. Qualifications: Ph.D. in Statistics or Biostatistics with 8-10+ years in pharmaceutical or biotech settings, experience with late-phase studies, clinical trial simulation, Bayesian/adaptive designs, and supporting NDA/MAA submissions. Skills include proficiency in SAS and R, excellent communication, and a basic understanding of biology/RNAi mechanisms. High-Value: Focus on RNAi therapeutics, late-stage clinical development, global regulatory engagement, and collaboration with various clinical and research stakeholders. Work Setup: Not specified.