Biostatistics Manager

Job title: Biostatistics Manager

About the Role Biostatistics Manager at Amgen will provide technical expertise and leadership to execute statistical deliverables for clinical studies, while building and integrating data visualization tools and ensuring compliance with regulatory standards.

What You'll Do

• Lead and oversee the application of biostatistical methods to analyze and interpret clinical trial data across multiple studies or programs, ensuring scientific rigor and consistency
• Provide strategic direction and oversight for statistical programming using R and Python, enabling scalable, efficient, and compliant data analysis and reporting solutions
• Manage and review the development of tables, listings, and figures (TLFs), as well as outputs supporting clinical study reports, publications, and regulatory submissions
• Ensure compliance with regulatory requirements, industry standards (including CDISC SDTM and ADaM), internal quality processes, and support audits and inspections as needed
• Collaborate with cross-functional teams to ensure timely delivery of study outputs
• Identify, prioritize, and implement process improvements, tools, and innovative technologies to advance statistical programming and reporting capabilities
• Stay current with emerging methodologies, technologies, and regulatory guidelines, and incorporate best practices into team workflows
• Provide leadership, mentorship, and technical guidance to statisticians and programmers, fostering a culture of continuous improvement and excellence
• Assist in developing and implementing AI-enabled technologies to streamline statistical workflows and build automated, reproducible reporting pipelines that enhance efficiency, quality, and traceability
• Manage self and other resources according to priorities
• Knowledgeable of developments in the field of statistics in drug development
• Contribute to the review and maintenance of Amgen policies, SOPs, and controlled documents to ensure ongoing compliance and align

What We're Looking For

• Experience leading biostatistics activities for clinical studies, with ability to provide strategic direction
• Proficiency in statistical programming using R and Python, enabling scalable and compliant data analysis and reporting
• Strong knowledge of CDISC SDTM and ADaM standards and regulatory guidelines, with ability to support audits and inspections
• Ability to collaborate with cross-functional teams and manage timely delivery of study outputs
• Track record of implementing process improvements and adopting innovative technologies in statistical programming
• Strong leadership, mentorship, and communication skills, with a focus on continuous improvement
• Familiarity with AI-enabled technologies to streamline workflows and build reproducible reporting pipelines

Nice to Have

• Experience with AI/ML in biostatistics or analytics, and familiarity with cloud-based data visualization tools