Responsibilities

• Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
• Cross-Functional Leadership: Serve as the statistical lead on multiple high-priority project teams. Collaborate with bench scientists, bioinformatics, and product development teams to integrate statistical expertise into project planning and execution. Proactively identify risks, communicate concerns, and champion solutions to interdisciplinary teams.
• Documentation and Reporting: Prepare comprehensive protocols and reports for cross-functional collaborators and stakeholders, ensuring clarity and precision.
• Regulatory Compliance: Ensure that statistical methodologies and analytical validations are compliant with regulatory standards. Prepare materials for regulatory submissions and support interactions with regulatory bodies.
• Mentorship: Mentor junior biostatisticians and contribute to their professional development by providing guidance and sharing knowledge in statistical methodologies and best practices.

Requirements

• Master's or PhD in Biostatistics, Statistics, or a related field.
• 5+ years of experience in biostatistics with a focus on analytical validation in the biotechnology or pharmaceutical industry.
• Strong knowledge of statistical methodologies and their application in clinical settings.
• Exceptional communication skills with the ability to explain complex statistical concepts to non-statistical audiences.
• Proficiency in statistical software (e.g., SAS, R) and a solid understanding of data management principles.
• Demonstrated ability to work independently and collaboratively within a team environment.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance plans.
• 401(k) retirement plan with company matching.
• Generous paid time off and holiday schedule.
• Opportunities for professional development and continuing education.
• A collaborative and innovative work environment that supports personal and professional growth.