VP, Head of Oncology Biometrics

ROLE SUMMARY

The Vice President, Head of Oncology Biometrics provides strategic and operational leadership for all biometrics activities supporting Oncology drug development across early- and late-stage programs. This role is accountable for ensuring high-quality statistical strategy, study design, analysis, and interpretation to enable sound clinical, regulatory, and portfolio decisions across the Oncology pipeline.

The VP leads global teams spanning biostatistics and related biometrics capabilities and partners closely with Clinical Development, Regulatory, Safety, Clinical Pharmacology, Translational Medicine, and other key stakeholders. The role ensures statistical integrity, regulatory compliance, innovation, and efficient execution in support of successful development, approval, and lifecycle management of Oncology medicines.

ROLE RESPONSIBILITIES

Strategic Leadership

• Set and drive the biometrics vision and strategy for Oncology programs across early and late development, ensuring alignment with overall Oncology R&D objectives.
• Provide strategic input to clinical development plans, protocol designs, statistical analysis plans, and program- and portfolio-level decision making.
• Serve as a senior thought partner to Oncology Development leadership on trial design, data interpretation, and risk mitigation.
• Forward thinking in innovative trial designs, new AI applications in biostatistics, biostatistics around translational efforts (ie - biomarker endpoints, dataset mining for patient segment patterns, potential new targets)

Biometrics Oversight & Execution

• Ensure high-quality, timely, and compliant statistical support for all Oncology clinical programs, including regulatory submissions and health authority interactions.
• Oversee the development, implementation, and execution of statistical methodologies, analyses, and reporting that support clinical protocols, study reports, and regulatory filings.
• Ensure statistical rigor, data integrity, and consistency with global regulatory standards and internal best practices.

People & Organizational Leadership

• Lead, develop, and retain a high-performing global biometrics organization, including succession planning and capability building.
• Foster a culture of scientific excellence, collaboration, innovation, and continuous improvement.
• Ensure appropriate resourcing and talent deployment across programs and therapeutic areas.

Cross‑Functional & External Engagement

• Partner effectively with Clinical Development, Regulatory Affairs, Safety, Biomarkers, Clinical Pharmacology, Real World Evidence, and other functions.
• Support interactions with global health authorities, including FDA and other regulators, on statistical strategy and data interpretation.
• Represent Oncology Biometrics in governance forums and cross‑functional decision‑making bodies.

Innovation & Continuous Improvement

• Drive adoption of innovative statistical methodologies, advanced analytics, and emerging technologies (e.g., data science, AI/ML where appropriate).
• Champion biometrics best practices, standards, and training through a Biometrics Center of Excellence model.
• Identify and address process, technology, and capability gaps to improve efficiency and impact.

Operational & Financial Accountability

• Accountable for planning and oversight of the Oncology Biometrics budget.
• Ensure effective use of internal and external resources to deliver high‑quality outcomes within timelines and cost targets.

BASIC QUALIFICATIONS

• PhD or equivalent advanced degree in Statistics, Biostatistics, or a closely related quantitative discipline.
• Extensive experience in biostatistics or biometrics within pharmaceutical or biotechnology drug development, with significant Oncology experience.
• Demonstrated leadership of global biometrics or statistics organizations supporting complex clinical development programs.
• Proven experience contributing to successful regulatory submissions and health authority interactions.
• Strong track record of strategic influence, cross‑functional leadership, and people development.

PREFERRED QUALIFICATIONS

• Deep expertise in clinical trial design, statistical methodology, and data interpretation.
• Strong understanding of global regulatory requirements and expectations for Oncology development.
• Excellent leadership, communication, and stakeholder‑management skills.
• Ability to balance scientific rigor with pragmatic decision making in a fast‑paced development environment.

The annual base salary for this pos