Senior Director, Biostatistics - Immunology & Inflammation

Senior Director, Biostatistics – Immunology & Inflammation Regeneron is seeking a Senior Director, Biostatistics to drive our Immunology and Inflammation therapeutic area. Responsibilities Strategic and operational activities for the Biostatistics department. Develop and implement departmental scientific policies and operational guidelines. Assist the Head, Biostatistics in administrative structure. Serve as senior research expert, leading within Global Development and statistical methodology for specific applications. Lead teams and structure function to manage anticipated growth in the product pipeline. Interface with senior leadership and medical study directors to provide and receive direction on clinical programs. Determine department goals and resource allocation in conjunction with the Department Executive Director. Ensure high-quality statistical support for study design, clinical development plans, and operational aspects. Work with senior management to ensure statistical representation in key project decisions and regulatory meetings. Represent the department on corporate-wide teams. Oversee process for statistical reporting and review critical documents (SAP, analysis result presentations, CSR, integrated summaries). Ensure compliance with data submission guidelines. Plan and track project activities, timelines, and resource use; provide justification for planned resource needs. Optimize resource utilization across projects or areas. Long-range planning, technical direction, mentoring for staff, and encourage personal development. Recruit, develop, and retain high quality staff. Maintain awareness of industry standards and regulatory requirements; alert staff to new or changing standards. Harmonize policies with departmental guidelines, SOPs, and industry standards; develop policies promoting corporate values in practices. Qualifications Ph.D. in statistics or related discipline with 10+ years of experience (or MS with 15+ years) in biotechnology, pharmaceutical, or health-related industry. Significant interaction with FDA and EMEA; experience across multiple therapeutic areas. History of successful project and people management (6+ years). Expertise in multiple therapeutic areas and active research interests related to clinical trial. Strong leadership, project management, teamwork, interpersonal skills. Excellent communication and presentation skills; ability to work independently, self‑directed with high energy and work ethic. Creativity, attention to detail; ability to work in changing, busy environment; exercise judgment applying policies and standards. Broad knowledge of advanced statistical concepts and techniques. Ability to represent Biostatistics and Data Management in senior management or cross‑functional committees. Thorough knowledge of clinical development lifecycle and regulatory guidelines; ability to apply principles to achieve regulatory approvals. Strong administrative and influence skills to achieve results. EEO Statement Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy, gender identity, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant if such accommodation would not impose undue hardship on the operation of the Company’s business. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc (USA)