Sr. Manager/ Associate Director, Statistical Programming

Role: Senior Manager/Associate Director of Statistical Programming leading statistical activities in clinical development at Avalo, focusing on immune-mediated inflammatory diseases targeting the IL-1β pathway. Responsibilities include overseeing programming for clinical trials, regulatory submissions, and publications; managing CRO/vendor relationships; collaborating with cross-functional teams (Biostatistics, Data Management, Clinical Ops, Medical, Regulatory); and driving standards, innovation, and process improvements in programming practices. Requirements: Master's in Statistics, Biostatistics, or related field; 7+ years (Senior Manager) or 9+ years (Associate Director) of biotech/pharma programming experience supporting clinical programs and regulatory submissions; expert SAS skills (Base, MACRO, SQL); knowledge of CDISC standards (SDTM, ADaM); familiarity with GxP, ICH, FDA, EMA guidelines; experience managing external vendors; strong project and stakeholder management skills. Preferred: supporting multiple phases from early development through submission, implementing automation, or modern analytics platforms. High-Value: Expertise in biologics/monoclonal antibodies, IL-1β inhibitor programs, clinical trial phases supporting IND/registrational studies, and regulatory compliance. Work setup: not specified.