Senior Biostatistician

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

• Recent small to midsized pharma/biotech experience required – no recent CRO experience)
• Long term experience at most roles (2+ years)

This position will serve as a lead or supporting statistician for late-phase oncology studies and will coordinate activities with other functional groups to ensure timely and high-quality deliverables.

Responsibilities

• Provide statistical expertise in the 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, including statistical modeling as needed.
• Collaborate with the statistical programmers to ensure that analyses are conducted per statistical plan and specifications.
• Collaborate with Data Management and Clinical Operations to ensure robust CRF and database development and quality data collection.
• Contribute to the development and review of publications, ensuring data consistency and accuracy.
• Author and review statistics related sections in Health Authority Submissions and Responses ensuring clarity, consistency and accuracy in data presentation.
• Represent biostatistics on study teams and contribute to cross-functional decision-making.

Required Skills, Experience and Education

• Ph.D. or M.S. in statistics or biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in the biotech/pharmaceutical industry as a statistician.
• Solid tumor late-stage drug development experience is required.
• Experience with NDA/BLA submission and interaction with Health Authorities is desirable.