Director of Biostatistics

Role: Lead statistical strategy for Oruka’s clinical development programs, spanning Phase I to IV studies for biologics targeting dermatologic and inflammatory diseases. Responsibilities: oversee study design, develop statistical analysis plans, author key documents, support data management and regulatory submissions, and manage CRO oversight. Qualifications: Ph.D. in Biostatistics or related field with 7+ years (or Master’s with 10+ years); expertise in clinical trial design, statistical modeling, and analysis; proficiency in SAS, knowledge of R beneficial; experience in immunology/inflammation preferred; familiarity with FDA/EMA, ICH-GCP, and CDISC standards; strong leadership, organizational, and communication skills. HighValue: biologics in dermatology/inflammation, Phase I-IV clinical trials, regulatory support, GxP compliance, CRO management. WorkSetup: remote or hybrid with 2-3 days onsite in Menlo Park, CA or Waltham, MA; no travel specified.