Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology) - Remote
Core
Lead statistical activities and strategy for clinical trials, primarily in Oncology, ensuring regulatory compliance and delivering high-quality analysis.
Role type
Senior Principal Biostatistician / Study Lead
Builds
Clinical study reports, Statistical Analysis Plans (SAPs), and Analysis Database Specifications (ADS) for pharmaceutical and biotech clients.
Domain
Clinical Research / Oncology / Biostatistics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Biostatistics, Oncology clinical trials, Statistical Analysis Plans (SAPs), Analysis Database Specifications (ADS), SAS programming, Regulatory compliance (FDA/ICH/GCP), Cross-functional collaboration
Preferred skills
Phase II–III trial leadership, Regulatory agency interaction, Mentoring junior statisticians
Technologies
SAS
Responsibilities
Lead statistical strategy for assigned studies, Author and review key statistical documents (SAPs, ADS, CSR sections), Review and interpret analysis outputs, Collaborate with Clinical, Programming, and Data Management teams, Communicate statistical results to stakeholders, Ensure adherence to regulatory standards
Seniority
Senior, hands-on IC with leadership responsibilities
