Principal, Biostatistician

Role: Lead biostatistician shaping statistical strategy for Denali's clinical programs from first-in-human to pivotal Phase 2/3 trials and NDA/MAA/BLA submissions. Responsibilities: develop statistical analysis plans, ensure integrity of analysis and reporting, oversee vendor and CRO deliverables, and lead exploratory analyses for ambiguous data. Collaborate with cross-functional teams and present findings to senior management. Requirements: Ph.D. in Statistics/Biostatistics or related field with 6+ years' experience, including late-stage trial planning and reporting; proficiency in R, Markdown, git, Unix/Linux; knowledge of CDISC standards. Preferred: experience influencing senior stakeholders, expertise in neurodegenerative disease modalities, and regulatory interactions. HighValue: clinical development lifecycle, Phase 2/3 trials, regulatory submissions, biostatistics leadership, and cross-functional influence. WorkSetup: not specified; compensation range $171,000–$223,000, with benefits.