Senior Director, Biostatistics

Location
South San Francisco, CA
Posted
May 09, 2022
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
About IDEAYA Biosciences:
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. 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 are applying these capabilities across multiple classes of precision medicine, including 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 recently announced a landmark strategic partnership with GSK in Synthetic Lethality for certain pipeline programs. The GSK partnership is transformative and enables IDEAYA and GSK to collectively build an industry leading platform and pipeline in Synthetic Lethality. For more information, please see www.ideayabio.com.

Position Summary:
The Senior Director, Biostatistics will be the leader of biostatistics and biometrics at IDEAYA and will oversee and provide the statistical support for 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 as well as regulatory submissions and publications. Will oversee, build, manage, and guide the IDEAYA statistics team and function (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 selection of 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.

What you’ll do:

    • Lead the clinical statistics function at IDEAYA.
    • Provide strategic input to IDEAYA leadership as a key member of strategic core that will oversee development of clinical development plans in coordination with operations, clinical, translational, regulatory, and commercial functions.
    • Set statistical standards and methods to ensure quality delivery of clinical, translational, and pharmacology datasets, all in coordination with each specific function and data management.
    • Oversee, author (as needed), review, and approve protocols, SAPs, DPPs, CRFs, CSRs, associated publications, and other study level specification documents.
    • Manage and oversee the statistical resources at IDEAYA, including all statistics personnel (line function members, programmers, consultants, and vendors) and statistical software analysis and storage systems.
    • Act as a resource and mentor to the entirety of the clinical development team. Translate scientific questions into statistical terms and statistical concepts into layman terms.  Challenge group assumptions and enforces rigorous analyses.
    • Assess, provide direction, and resolves complex stakeholder concerns and represent the IDEAYA biostatistics function externally.
    • Stay current with applied statistical methodology and regulatory standards.

Requirements:

    • Ph.D. or M.S. in Statistics or closely related field.
    • Have 10+ (or 13+ years for MS) years statistical experience in drug development (including at least 5 years in pharmaceutical industry R&D).
    • Experience with oncology clinical development.
    • Experience across the development lifecycle from IND to approval.
    • Expert knowledge of clinical trial design concepts and statistical methodologies including Bayesian approaches as well as survival analyses.
    • Experience in management within the statistical line function.
    • Demonstrated ability to work in a team environment with clinical team members with good interpersonal, communication, writing and organizational skills.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

Benefits
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.

Ideaya is an equal opportunity employer. In accordance with applicable law, Ideaya does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

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