Director Biostatistics Late Stage Oncology Leader

Director, Biostatistics Late Stage Oncology Leader

Overview

A global biopharmaceutical organization is seeking a Director, Biostatistics to provide strategic statistical leadership across oncology clinical development programs. This individual will serve as the senior biostatistics lead for multiple assets/indications, shaping development strategy, driving high-quality execution, and acting as a key scientific partner to Clinical, Regulatory, and Evidence Generation leadership.

This is a highly visible role for a hands-on statistical leader who enjoys influencing decisions at the program and portfolio level while maintaining technical depth. This leader will have the potential to have multiple direct reports.

Key Responsibilities

Strategic & Scientific Leadership

• Serve as the lead biostatistics representative and subject-matter expert for oncology development programs
• Own and drive statistical strategy across study design, analyses, interpretation, and decision-making
• Partner cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and Evidence Generation teams
• Propose innovative trial designs, methodologies, and data-driven decision frameworks to optimize probability of success

Execution & Oversight

• Accountable for the quality, timeliness, and scientific rigor of biostatistical deliverables across multiple studies or assets
• Oversee internal statisticians and CRO partners; ensure best practices, consistency, and compliance
• Proactively identify statistical risk and develop mitigation strategies across programs
• Optimize resource allocation and capacity planning to support development priorities

Regulatory & External Engagement

• Lead biostatistics contributions to regulatory interactions, submissions, and responses
• Own statistical components of protocols, CSRs, integrated summaries, and regulatory packages
• Represent Biostatistics in discussions with health authorities and external scientific stakeholders
• Oversee publication strategy, including review and approval of abstracts, posters, and manuscripts

Leadership & Continuous Improvement

• Contribute to talent development through mentoring, coaching, and selective line management
• Support recruitment, retention, and career development of biostatistics talent
• Lead or influence process improvements, standards development, and quality documentation

Qualifications

• PhD in Biostatistics or a closely related field (MS considered with significant industry experience)
• ~9+ years of pharmaceutical or biotechnology experience supporting clinical development
• Deep expertise in statistical methods across all phases of clinical trials; oncology experience strongly preferred
• Demonstrated success influencing development strategy and regulatory outcomes
• Strong knowledge of SAPs, TFLs, regulatory guidance (ICH, FDA, EMA), and submission requirements
• Experience managing CROs and cross-functional stakeholders
• Proficiency in SAS strongly preferred
• Executive presence with the ability to communicate complex statistical concepts to senior leaders

Location & Work Model

• Hybrid (2-3 days onsite) or fully remote within the U.S. with occasional travel

Compensation

• $240,000-$270,000 base salary + 25% bonus + LTI + additional benefits