Senior Director, Biostatistics

Ideaya Biosciences • South San Francisco, CA

103d • $295,000 - $310,000 • Remote

About The Position

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.

Requirements

• Ph.D. or M.S. in Statistics or closely related field.
• 15+ years statistical experience in drug development, including at least 10 years in oncology drug development 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 time-to-event analysis methodologies.
• Demonstrated strong ability and leadership to work in a cross-functional team environment with good interpersonal, communication, writing and organizational skills.

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 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.
• 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.
• 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.

Benefits

• Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
• 401k
• ESPP
• Wellness programs
• Merit-based salary increases
• Company discretionary short-term incentive plan participation
• Company discretionary stock option awards (based on board approval)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree