Director Biostatistics

Role: Lead biostatistics strategy and execution for clinical development at Mineralys, focusing on hypertension, CKD, and related disorders, supporting NDA readiness. Responsibilities: design and analyze clinical trials, define statistical strategies, serve on Study and Development Teams, oversee CROs, ensure quality and compliance of statistical deliverables, contribute to regulatory submissions, and support regulatory interactions. Qualifications: PhD in Biostatistics or related field (~8+ years industry experience) or MS (~11+ years), with strong background in clinical trial design, statistical analysis, and regulatory support; experience with NDA/BLA submissions, CRO oversight, and CDISC standards; proficiency in SAS/R preferred. High-Value: Therapeutic areas include chronic diseases, with focus on early and late-stage clinical trials; international or regulatory agency interaction experience advantageous. Work setup: Fully remote, with up to 10% travel.