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.
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.
What you'll do: 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.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.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.This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
The expected salary range for this role that is based in our South San Francisco, California office is $290,460 - $306,690.
The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.
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.
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