Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology)

📋 Description

• Lead and provide statistical support for clinical studies, primarily within Oncology.
• Lead statistician on assigned studies, overseeing statistical strategy and deliverables.
• Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance.
• Collaborate with cross-functional teams including Clinical, Programming, Data Management, and
• Communicate statistical concepts, results, and risks clearly to both technical and non-technical
• Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs.

🎯 Requirements

• MS or PhD in Statistics, Biostatistics, or a related field
• Strong experience in Oncology studies
• SAS programming skills required
• Hands-on experience writing Statistical Analysis Plans (SAPs) and Analysis Database Specifications
• Experience leading Phase II–III clinical trials and mentoring junior staff
• Experience interacting with regulatory agencies

🎁 Benefits

• Competitive compensation and benefits
• Medical, dental, and vision coverage
• Paid time off and holidays