Senior Director, Safety Biostatistics

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.

Location: South San Francisco, CA. This position requires onsite presence four days per week per company policy.

About the role

IDEAYA is seeking a Senior Director of Safety Biostatistics to join the Biometrics team. This role will lead Biostatistics and Biometrics at IDEAYA, overseeing and providing strong statistical support for the development of IDEAYA therapeutics in close collaboration with Clinical Development, Regulatory Affairs, Data Management, Program Management, and especially Drug Safety and Pharmacovigilance.

The Senior Director will be a key contributor to Clinical Development Plans, including the creation and execution of clinical protocols, statistical analysis plans (SAPs), Investigator Brochures (IB), Development Safety Update Reports (DSUR), regulatory submissions, and publications. This role involves significant stakeholder management and responsibility for driving optimal study designs, data collection, analytic approaches, and rigorous interpretation of data, particularly in drug safety.

Responsibilities

• Lead Biometrics members in cross-functional teams at IDEAYA.
• Provide strategic input to IDEAYA clinical teams and oversee development of clinical development plans and protocols in coordination with Drug Safety, 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, SAPs, Case Report Forms (CRFs), IBs, 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, 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 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.

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 for oncology drugs.
• Expert knowledge of clinical trial design concepts and statistical methodologies with an in-depth understanding of safety analysis.
• Demonstrated strong leadership ability to work in a cross-functional team environment with excellent interpersonal, communication, writing, and organizational skills.

Benefits

• Comprehensive medical, dental, and vision coverage (100% company-paid for employees and 90% company-paid for dependents).
• 401k retirement plan.
• Employee Stock Purchase Plan (ESPP).
• Wellness programs.
• Company discretionary short-term incentive plan participation.
• Company discretionary stock option awards (based on board approval).

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 location, experience, education, and performance during the interview process.