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

Key Responsibilities

• Lead and provide statistical support for clinical studies, primarily within Oncology
• Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables
• Author and review key statistical documents, including:
  • Statistical Analysis Plans (SAPs)
  • Analysis Database Specifications (ADS)
  • Statistical sections of clinical study reports
• Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance
• Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory
• Provide guidance and oversight to statistical programmers as needed
• Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders
• Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs

Required Qualifications

• MS or PhD in Statistics, Biostatistics, or a related field
• Strong experience in Oncology studies
• Hands-on experience writing:
  • Statistical Analysis Plans (SAPs)
  • Analysis Database Specifications
  • Reviewing and interpreting analysis results
• SAS programming skills required (hands-on or strong working knowledge)
• Excellent written and verbal communication skills
• Experience working in a CRO and/or pharmaceutical/biotech environment

Preferred Qualifications

• Experience leading Phase II–III clinical trials
• Prior interaction with regulatory agencies
• Experience mentoring junior statisticians or programmers