Senior Director, Safety Biostatistics

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 (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 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.

About the Role

IDEAYA is seeking a Senior Director of Safety Biostatistics to join IDEAYA’s Biometrics team in South San Francisco, CA. This role is based in our headquarters and requires onsite presence four days per week per company policy.

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 Drug Safety and Pharmacovigilance.

This role has significant stakeholder management responsibility with business partners and involves driving optimal study designs, data collection, analytic approaches, and rigorous interpretation of data, particularly in drug safety. The position reports to the Senior Director of Biostatistics.

Responsibilities

• Lead the Biometrics members in cross-functional teams at IDEAYA.
• 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 in coordination with each specific function and data management.
• Oversee, author (as needed), review, and approve protocols, statistical analysis plans (SAPs), case report forms (CRFs), investigator brochures (IBs), development safety update reports (DSURs), clinical study reports (CSRs), associated publications, and other study and program-level documents.
• Manage and/or oversee the biostatistical teams on 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 tables, figures, and listings (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 team needs.
• Challenge group assumptions and enforce rigorous statistical methodologies.
• Assess, provide direction, and resolve complex stakeholder concerns; represent the IDEAYA biostatistics function internally and externally.
• Stay current with applied statistical methodology and regulatory standards.
• Serve as the statistical representative in the defense of the company position and approach on statistical issues and drug approvals globally.

Requirements

• Ph.D. or M.S. in Statistics or a closely related field.
• 15+ years of statistical experience in drug development, including at least 10 years in oncology drug development and 8 years of extensive experience supporting Drug Safety and Pharmacovigilance in pharmaceutical industry R&D.
• Extensive hands-on experience writing complex protocols and SAPs, performing interim and CSR analyses in the oncology clinical development lifecycle from Phase 1 study to regulatory submission.
• Direct involvement and responsibility in multiple NDA/BLA submissions with track records of approval of oncology drugs.
• Expert knowledge of clinical trial design concepts and statistical methodologies with an in-depth understanding of safety analysis.
• Demonstrated strong ability and leadership to work in a cross-functional team environment with excellent interpersonal, communication, writing, and organizational skills.

Benefits

• Competitive total rewards package reflecting a pay-for-performance philosophy, including merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).
• Comprehensive benefits package including medical, dental, and vision coverage (100% company-paid for employees and 90% company-paid for dependents).
• 401k, Employee Stock Purchase Plan (ESPP), and wellness programs.

Pay

The expected salary range for the role of Senior Director, Safety Biostatistics is $270,000 - $334,000. The final salary offered will depend on factors such as office location, candidate’s experience, expertise in disease areas relevant to IDEAYA, industry tenure, educational background, and performance during the interview process.

Schedule

This position requires onsite work at the company’s South San Francisco headquarters four days per week, with work-from-home flexibility for the remaining day.