Senior Director, Safety Biostatistics

Job Summary

About IDEAYA Biosciences: IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Position Summary

IDEAYA is seeking a Senior Director of Safety Biostatistics to join IDEAYA’s Biometrics team. The Senior Director of Safety Biostatistics will be a leader of Biostatistics and Biometrics at IDEAYA and will oversee and provide strong statistical support to the development of IDEAYA therapeutics in close collaboration with Clinical Development, Regulatory Affairs, Data Management, Program Management, and especially with focus with Drug Safety and Pharmacovigilance. Will be a key contributor to Clinical Development Plans, including the creation and execution of clinical protocols, statistical analysis plans (SAPs), and with focus in IB and DSUR as well as regulatory submissions and publications. Will oversee, manage, and guide the IDEAYA biostatistics team (both internally and externally) to ensure high quality and timely deliverables. Will serve as the statistical representative in the defense of the company position and approach on statistical issues and drug approvals globally. This role has significant stakeholder management responsibility with business partners. The biostatistician leader has responsibility for driving optimal study designs, data collection, analytic approaches, and rigorous interpretation of data in general and especially in drug safety. This person will interact with external vendors, key opinion leaders and regulatory agencies in supporting safety aspect of statistical applications. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

What you’ll do

• Lead the Biometrics members in cross-functional teams at IDEAYA.
• As a key member, provide strategic input to IDEAYA clinical teams, oversee development of clinical development plans and protocols in coordination with drug safety and pharmacovigilance, clinical sciences, clinical pharmacology, regulatory, and commercial functions.
• Set statistical standards and methods to ensure quality delivery of clinical and pharmacology datasets, all in coordination with each specific function and data management.
• Oversee, author (as needed), review, and approve protocols, SAPs, CRFs, IBs, DSURs, CSRs, associated publications, and other study and program level documents.
• Manage and/or oversee the biostatistical teams on the responsible drug development programs at IDEAYA, including biostatistics personnel (line function members, programmers, consultants, and vendors) to produce and standardize statistical software and generate high quality TFLs.
• Act as a resource and mentor to the development teams of the responsible clinical programs.
• Translate scientific questions into statistical terms and statistical concepts into layman terms to support the team needs.
• Challenge group assumptions and enforce rigorous statistical methodologies.
• Assess, provide direction, and resolve complex stakeholder concerns and represent the IDEAYA biostatistics function internally and externally.
• Stay current with applied statistical methodology and regulatory standards.

Requirements

• Ph.D. or M.S. in Statistics or closely related field.
• Have 15+ years statistical experience in drug development, including at least 10 years in oncology drug development and 8 years extensive experience in supporting Drug Safety and Pharmacovigilance in pharmaceutical industry R&D.
• Extensive hands-on experience from writing complex protocols and SAPs to performing interim and CSR analyses in oncology clinical development lifecycle from Phase 1 study to regulatory submission.
• Direct involvement and responsibility and hands-on experience 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 in safety analysis.
• Demonstrated strong ability and leadership to work in a cross-functional team environment with good interpersonal, communication, writing and organizational skills.