Senior Director, Biostatistics jobs in United States
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IDEAYA Biosciences · 21 hours ago

Senior Director, Biostatistics

IDEAYA Biosciences is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. The Senior Director, Biostatistics will lead the biostatistics team, providing statistical support for the development of IDEAYA therapeutics and ensuring high quality deliverables in collaboration with various departments.

BiotechnologyHealth CareOncologyTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Lead the Biometrics members in cross-functional teams at IDEAYA
As a key member, 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, all in coordination with each specific function and data management
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, including all biostatistics personnel (line function members, programmers, consultants, and vendors) to produce statistical software and generate high quality 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 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

Qualification

Ph.D. in StatisticsOncology drug developmentClinical trial designStatistical methodologiesProtocol writingCross-functional leadershipInterpersonal skillsCommunication skillsOrganizational skills

Required

Ph.D. or M.S. in Statistics or closely related field
Have 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

Benefits

Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
401k
ESPP
Wellness programs

Company

IDEAYA Biosciences

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IDEAYA Biosciences is an oncology-focused biotechnology company that develops therapeutics for patients with genetically-defined cancers.

H1B Sponsorship

IDEAYA Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (2)
2023 (3)
2022 (4)
2021 (1)

Funding

Current Stage
Public Company
Total Funding
$694.1M
Key Investors
5AM Ventures
2024-07-09Post Ipo Equity· $263M
2023-10-24Post Ipo Equity· $125M
2022-09-14Post Ipo Equity· $80M

Leadership Team

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Yujiro S. Hata
CEO
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Paul A. Stone
Chief Financial Officer & General Counsel
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Company data provided by crunchbase