Biostatistician - Late Stage

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.

Requirements

• 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.
• Proficiency in SAS and/or R.

Preferred Qualifications

• Ability to work independently and within a team.
• Excellent verbal and written communication skills are required.
• Good interpersonal and project management skills are essential.

Skills

• Biostatistics
• Statistical Analysis
• Clinical Study Design
• Clinical Trial Analysis
• Late-Phase Oncology Studies
• Solid Tumor Drug Development
• Statistical Modeling
• Statistical Analysis Plans
• Analysis Specifications
• Quality Control
• Cross-Functional Collaboration
• Statistical Programming Collaboration
• Data Management
• Clinical Operations
• CRF Development
• Database Development
• Data Quality
• Publication Review
• Health Authority Submissions
• NDA/BLA Submissions
• Regulatory Responses
• Data Presentation
• Study Team Leadership
• Decision-Making
• SAS
• R
• Project Management
• Written Communication
• Verbal Communication
• Biotechnology
• Pharmaceuticals

Pay

$90 - $100 per hour

Candidates must qualify as a W2 candidate. This is a remote role based in Redwood City, CA.