Sr. Manager/ Associate Director, Biostatistics

Role: Lead biostatistics strategy and operations across clinical development programs targeting immune-mediated inflammatory diseases, focusing on IL-1β pathway therapeutics. Responsibilities include designing and optimizing clinical trials, developing analysis plans, interpreting data, and supporting regulatory submissions and interactions. The role involves collaboration with cross-functional teams such as Clinical Development, Medical Affairs, Data Management, and Regulatory Affairs, with oversight of external vendors like CROs. Key contributions encompass statistical methodology innovation, evidence generation (including post-marketing and observational studies), and ensuring compliance with global regulatory standards (ICH, FDA, EMA). Qualifications: Ph.D. or M.S. in Biostatistics, Statistics, or related with 4-8+ years of industry experience; proven leadership in clinical trial statistics, study design, and regulatory support; proficiency in SAS/R; knowledge of immunology/inflammatory disease is preferred. The position emphasizes strategic input in early to late-phase development, with experience in adaptive and longitudinal analyses highly valued. The seniority level varies from Senior Manager to Associate Director, reflecting increasing leadership responsibilities. High-Value: focus on immunology/inflammation, biologics (anti-IL-1β mAbs), clinical development stages from early to registration, regulatory interactions, and a strong emphasis on cross-functional and external vendor collaboration. Work setup specifics and travel are not specified.