Biostatistician, Late Stage

Biostatistician, Late Stage

W2 Contract

Pay Rate: $100 - $125 per hour

Location: Redwood City, CA - Hybrid Role

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 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 and Qualifications:

• 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.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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