Senior Director, Safety Biostatistics

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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. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com. Location: South San Francisco, CA. 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. Reporting to: Senior Director, Biostatistics Job Description 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