Biostatistician, Late Stage

Pay Rate: $100 – $130 per hour | Location: Redwood City, CA – Remote

Job Summary

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.

Duties and 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 quality control on statistical analyses, including statistical modeling as needed.
• Collaborate with statistical programmers to ensure 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 and Qualifications

• Ph.D. or M.S. in statistics or biostatistics.
• Minimum of 5 years (Ph.D.) or 8 years (M.S.) 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.
• Good interpersonal and project management skills.

Desired Skills and Experience

• Biostatistics for late‑phase oncology clinical trials
• Solid tumor drug development
• Clinical study design
• Statistical analysis and reporting
• Statistical analysis plans and analysis specifications
• Statistical modeling and quality control
• SAS and R programming
• Collaboration with statistical programmers
• CRF design and clinical database development
• Data management and clinical operations
• Data quality assurance
• Publication development and review
• NDA/BLA submissions and health authority interactions
• Regulatory data presentation
• Cross‑functional collaboration and study team leadership
• Decision‑making and project management
• Independent work and teamwork
• Strong written and verbal communication
• Interpersonal skills
• 5–8+ years of biotech or pharmaceutical industry experience

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Candidates must qualify as a W2 employee.