AD Biostatistics Late Stage Oncology

Associate Director, Biostatistics - Late Stage Oncology

Location: New Jersey (Hybrid - Minimum 3 days onsite per week)

Salary: 185-215,000 base salary + 20% bonus + additional benefits

We are seeking a highly skilled and motivated Associate Director, Biostatistics to join our growing team. In this role, you will provide strategic statistical leadership and expertise across the design, execution, and analysis of clinical trials and experimental studies. Partnering with cross-functional teams, you will drive evidence-based decision-making and contribute to the advancement of our research and development programs.

This position requires a minimum of three days per week onsite in our New Jersey office (or more as business needs dictate) to ensure effective collaboration, operational excellence, and support for significant team growth.

Key Responsibilities

• Collaborate with interdisciplinary teams to design clinical trials and experimental studies, ensuring robust statistical methodologies.
• Lead development of statistical analysis plans, including endpoints, sample size determination, randomization strategies, and statistical approaches.
• Perform advanced statistical analyses on complex datasets and translate findings into actionable insights.
• Provide mentorship and guidance to biostatisticians and statistical programmers.
• Contribute to regulatory submissions by authoring and reviewing statistical sections of documents.
• Stay abreast of emerging trends, tools, and best practices in biostatistics and their application in biotechnology.
• Drive adoption and implementation of advanced statistical tools and software.

Qualifications

• Ph.D. (or equivalent) in Statistics, Biostatistics, or a related discipline with 6+ years of experience in clinical research and drug development.
• Proficiency in statistical programming languages (e.g., R, SAS) and familiarity with data visualization tools.
• Strong understanding of regulatory guidelines (ICH, FDA) and their impact on statistical analysis and reporting.
• Proven experience authoring statistical analysis plans and generating tables, listings, and figures. Oncology experience is preferred (Phase II/III).
• Excellent communication skills with the ability to explain complex statistical concepts to non-technical stakeholders.
• Demonstrated leadership and team mentorship capabilities.
• Experience with Bayesian statistics and adaptive trial designs.
• Publications in peer-reviewed journals highlighting contributions to biostatistics.