Lead Biostatistician—Oncology, Late-Phase Trials

Redbock - an NES Fircroft company; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a lead statistician to join late-phase oncology studies. The role coordinates with cross-functional teams to ensure timely, high-quality deliverables across study design, analysis and reporting.

The candidate will provide statistical expertise, develop SAPs, perform QC, and collaborate with data management and clinical operations. NDA/BLA submissions experience desirable and a strong publication record is a plus.

Qualifications

• Ph.D. or M.S. in statistics or biostatistics with biotech/pharma industry experience.
• Solid tumor late-stage drug development experience required.
• Experience with NDA/BLA submissions and Health Authority interactions desirable.

Responsibilities

• Provide statistical expertise in design, analysis and reporting of clinical studies.
• Partner with cross-functional teams to define analysis scope and timeline.
• Develop statistical analysis plans and detailed analysis specifications.
• Conduct and perform QC on statistical analyses.
• Collaborate with statistical programmers to ensure analyses follow the plan and specifications.
• Collaborate with Data Management and Clinical Operations to ensure robust data collection.
• Contribute to the development and review of publications with data consistency and accuracy.
• Author and review statistics sections in Health Authority submissions and responses.

Skills

Statistical analysis

Biostatistics

Cross-functional collaboration

Documentation

Education

Ph.D. in statistics/biostatistics

M.S. in statistics/biostatistics

Job description

Redbock - an NES Fircroft company is seeking a lead statistician to join late-phase oncology studies. The role coordinates with cross-functional teams to ensure timely, high-quality deliverables across study design, analysis and reporting.

The candidate will provide statistical expertise, develop SAPs, perform QC, and collaborate with data management and clinical operations. NDA/BLA submissions experience desirable and a strong publication record is a plus.