Senior Director, Biostatistics

Role: Senior Director, Biostatistics overseeing all statistical aspects of biosimilar development at Amgen. Objectives include providing strategic statistical input, leading biostatistics teams, overseeing CRO performance, and shaping statistical methodologies for biosimilars. Responsibilities encompass protocol and analysis plan oversight, ensuring statistical standards in study design and reporting, supporting regulatory submissions, and representing statistical approaches in external and internal meetings. The role involves staff management, development of policies, and advancing scientific research in biostatistics. High-value details include expertise in biosimilar development, global regulatory standards, and non-inferiority trial design. Collaboration spans internal teams, CROs, regulatory agencies, and scientific leaders. The position requires a Doctorate in Statistics/Biostatistics with at least 5 years of senior leadership experience, or equivalent with a Master’s/Bachelor’s degree and extensive industry experience. Preferred qualifications include proven leadership in regulatory submissions, strong communication skills, and specific experience in biosimilars, including global regulatory knowledge and life cycle drug development. Work setup details are not specified, but the role likely involves cross-functional coordination within a global biopharma environment.