Manager Biostatistics (Study Lead Statistician)

Responsibilities

• Provide statistical expertise and quality control for study design documents, including protocols and Key Design Elements (KDE).
• Serve as the GBS lead on the Clinical Study Team Leadership Team to execute clinical trials and perform risk assessments.
• Oversee statistical contributions to randomization specifications, statistical analysis plans (SAPs), and TFL shells.
• Collaborate cross-functionally to deliver scientifically rigorous analysis results for Clinical Study Reports (CSRs) and publications.
• Communicate study-specific findings and insights effectively with internal and external stakeholders.
• Review deliverables from external suppliers to ensure quality and adherence to regulatory standards.
• Assist with the development and implementation of AI technology to streamline statistical workflows.

Requirements

• MSc or PhD in Statistics, Biostatistics, or a related field.
• At least 8 years of relevant industry experience in a Study Lead Statistician capacity.
• Proven experience applying statistical methods within clinical development.
• Experience in machine learning and life-cycle drug development.
• Ability to work effectively within globally dispersed, cross-cultural teams.

Preferred Qualifications

• Doctorate degree in Statistics or Biostatistics.
• Experience with real-world data (RWD) analytics or electronic health record (EHR) data analysis.
• Expertise in clinical trial simulation or related advanced applications.

About the Company

Amgen is a leading global biotechnology company dedicated to unlocking the potential of biology to serve patients with serious illnesses. By leveraging advanced human genetics and biologics manufacturing expertise, Amgen discovers and delivers innovative human therapeutics to millions of patients worldwide.