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
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