Senior Director, Biostatistics

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality, which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK, Amgen, Pfizer, and Gilead but wholly-owns or controls its three most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.  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 teamwork to move science forward. For more information, please see www.ideayabio.com.
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources.  Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio.  Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com 
Position Summary: The Senior Director, Biostatistics will be a leader of Biostatistics and Biometrics at IDEAYA and will oversee and provide statistical support to the development of IDEAYA therapeutics in close collaboration with Clinical Development, Regulatory Affairs, Drug Safety, Clinical Pharmacology, Data Management, Translational Development and Program Management team members. Will be a key contributor to Clinical Development Plans, including the creation and execution of clinical protocols and statistical analysis plans (SAPs) 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. This person will interact with external vendors, key opinion leaders and regulatory agencies.
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 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, all in coordination with each specific function and data management.
• Oversee, author (as needed), review, and approve protocols, SAPs, CRFs, CSRs, associated publications, and other study level documents.
• Manage and/or oversee the biostatistical teams on the responsible drug development programs at IDEAYA, including all biostatistics personnel (line function members, programmers, consultants, and vendors) to produce 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 suppo