Senior Director, Biostatistics

Role Summary

We are seeking a Senior Director, Biostatistics to join IDEAYA’s Biometrics department. The Senior Director, Biostatistics will oversee and provide statistical support to the development of IDEAYA therapeutics in collaboration with Clinical Development, Regulatory Affairs, Drug Safety, Clinical Pharmacology, Data Management, Translational Development and Program Management. They will contribute to Clinical Development Plans, including the creation and execution of clinical protocols and statistical analysis plans (SAPs) as well as regulatory submissions and publications. The role includes overseeing the IDEAYA biostatistics team (internal and external) to ensure high quality and timely deliverables, acting as the statistical representative in regulatory discussions globally, and engaging with external vendors, key opinion leaders, and regulatory agencies. Location: South San Francisco, CA.

Responsibilities

• Lead the Biometrics team in cross-functional IDEAYA teams.
• Provide strategic input to clinical teams, overseeing development of clinical development plans and protocols in coordination with clinical operations, clinical sciences, clinical pharmacology, regulatory, and commercial functions.
• Set statistical standards and methods to ensure quality delivery of clinical, translational medicine, and pharmacology datasets, in coordination with each function and data management.
• Oversee, author (as needed), review, and approve protocols, SAPs, CRFs, CSRs, publications, and other study-level documents.
• Manage and/or oversee the biostatistical teams on responsible drug development programs, including all biostatistics personnel, to produce statistical software and high-quality TFLs.
• Act as a resource and mentor to development teams; translate scientific questions into statistical terms and communicate statistical concepts to non-statistical colleagues; challenge assumptions and enforce rigorous methodologies.
• Assess, provide direction, and resolve complex stakeholder concerns, representing the IDEAYA biostatistics function internally and externally.

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 pharmaceutical R&D.
• Extensive hands-on experience writing complex protocols and SAPs and performing interim and CSR analyses across the oncology clinical development lifecycle from Phase 1 to regulatory submission.
• Direct involvement in multiple NDA/BLA submissions with track records of approval of oncology drugs.
• Expert knowledge of clinical trial design concepts and statistical methodologies with in-depth understanding of time-to-event analysis methodologies.
• Strong leadership and ability to work in a cross-functional team with excellent interpersonal, communication, writing, and organizational skills.

Education

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