Senior Director, Biostatistics

Role Summary

We are seeking a Senior Director, Biostatistics to join IDEAYA’s Biometrics department. The Senior Director, Biostatistics will lead Biostatistics and Biometrics, oversee statistical support for IDEAYA therapeutics, contribute to Clinical Development Plans, SAPs, regulatory submissions, and publications, and manage the internal and external biostatistics team. They will act as the statistical representative on global drug approvals, drive study design and data interpretation, and collaborate with external vendors, key opinion leaders, and regulatory agencies.

Responsibilities

• Lead the Biometrics team in cross-functional IDEAYA teams.
• Provide strategic input to clinical teams and oversee development of clinical development plans and protocols with clinical operations, clinical sciences, clinical pharmacology, regulatory, and commercial functions.
• Set standards and methods to ensure quality delivery of clinical, translational medicine, and pharmacology datasets in coordination with data management.
• Oversee, author (as needed), review, and approve protocols, SAPs, CRFs, CSRs, publications, and other study documents.
• Manage biostatistical teams (line function, programmers, consultants, and vendors) to produce statistical software and high-quality results.
• Mentor development teams, translate scientific questions into statistical terms, challenge assumptions, and enforce rigorous methodologies.
• Represent the IDEAYA biostatistics function internally and externally, resolve stakeholder concerns, and stay current with applied statistics and regulatory standards.

Qualifications

• Ph.D. or M.S. in Statistics or closely related field.
• 15+ years of statistical experience in drug development, including at least 10 years in oncology drug development in pharma R&D.
• Hands-on experience writing complex protocols and SAPs and performing interim and CSR analyses across oncology clinical development from Phase 1 to regulatory submission.
• Direct involvement in multiple NDA/BLA submissions with track records of oncology drug approvals.
• Expert knowledge of clinical trial design concepts and statistical methodologies, with deep understanding of time-to-event analyses.
• Strong leadership and cross-functional collaboration skills with excellent interpersonal, communication, writing, and organizational abilities.

Skills

• Statistical leadership in cross-functional teams
• Clinical development planning and protocols
• Regulatory submissions and publications
• Time-to-event analysis and advanced statistical methodologies
• Vendor management and stakeholder communication

Education

• Ph.D. or M.S. in Statistics or closely related field

Additional Requirements

• Onsite work required at IDEAYA facilities; travel as needed for collaborating with external partners may be expected.