BioSpace
Senior Director, Biostatistics
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BioSpace
Join our precision medicine oncology company, IDEAYA Biosciences, to lead the Biostatistics and Biometrics team for transformative cancer therapies.
Location: South San Francisco, CA.
Position Summary We are seeking a Senior Director, Biostatistics to join IDEAYA’s Biometrics department. The senior director will 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 teams. The role will contribute to clinical development plans, including creation and execution of clinical protocols and statistical analysis plans (SAPs), regulatory submissions, and publications. The senior director will oversee the IDEAYA biostatistics team (internal and external) and serve as the statistical representative in global drug approvals.
What you’ll do
Lead the Biometrics members in cross‑functional teams at IDEAYA.
Provide strategic input to clinical teams, oversee development of clinical plans and protocols.
Set statistical standards and methods to ensure quality delivery of clinical, translational medicine, and pharmacology datasets.
Oversee, author, 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, producing high‑quality statistical software and TFLs.
Act as a resource and mentor to the development teams, translating scientific questions into statistical terms and vice versa.
Assess, provide direction, and resolve complex stakeholder concerns and represent the 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 in pharmaceutical industry R&D.
Extensive hands‑on experience writing complex protocols and SAPs to performing interim and CSR analyses throughout the oncology clinical development lifecycle from Phase 1 to regulatory submission.
Direct involvement and responsibility for multiple NDA/BLA submissions with track records of approval of oncology drugs.
Expert knowledge of clinical trial design concepts and statistical methodologies, particularly time‑to‑event analysis.
Demonstrated strong ability and leadership to work in a cross‑functional team environment with good interpersonal, communication, writing and organizational skills.
Total Rewards IDEAYA offers a competitive total rewards package that reflects our pay‑for‑performance philosophy. Employees may be eligible for merit‑based salary increases, discretionary short‑term incentive plans, and discretionary stock option awards. Comprehensive benefits include medical, dental, vision coverage, 401(k), ESPP, and wellness programs.
Compensation Expected salary range for Senior Director, Biostatistics: $295,000 – $310,000.
Legal and Employment Information 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. This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with work‑from‑home flexibility, 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.
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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at
BioSpace
Join our precision medicine oncology company, IDEAYA Biosciences, to lead the Biostatistics and Biometrics team for transformative cancer therapies.
Location: South San Francisco, CA.
Position Summary We are seeking a Senior Director, Biostatistics to join IDEAYA’s Biometrics department. The senior director will 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 teams. The role will contribute to clinical development plans, including creation and execution of clinical protocols and statistical analysis plans (SAPs), regulatory submissions, and publications. The senior director will oversee the IDEAYA biostatistics team (internal and external) and serve as the statistical representative in global drug approvals.
What you’ll do
Lead the Biometrics members in cross‑functional teams at IDEAYA.
Provide strategic input to clinical teams, oversee development of clinical plans and protocols.
Set statistical standards and methods to ensure quality delivery of clinical, translational medicine, and pharmacology datasets.
Oversee, author, 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, producing high‑quality statistical software and TFLs.
Act as a resource and mentor to the development teams, translating scientific questions into statistical terms and vice versa.
Assess, provide direction, and resolve complex stakeholder concerns and represent the 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 in pharmaceutical industry R&D.
Extensive hands‑on experience writing complex protocols and SAPs to performing interim and CSR analyses throughout the oncology clinical development lifecycle from Phase 1 to regulatory submission.
Direct involvement and responsibility for multiple NDA/BLA submissions with track records of approval of oncology drugs.
Expert knowledge of clinical trial design concepts and statistical methodologies, particularly time‑to‑event analysis.
Demonstrated strong ability and leadership to work in a cross‑functional team environment with good interpersonal, communication, writing and organizational skills.
Total Rewards IDEAYA offers a competitive total rewards package that reflects our pay‑for‑performance philosophy. Employees may be eligible for merit‑based salary increases, discretionary short‑term incentive plans, and discretionary stock option awards. Comprehensive benefits include medical, dental, vision coverage, 401(k), ESPP, and wellness programs.
Compensation Expected salary range for Senior Director, Biostatistics: $295,000 – $310,000.
Legal and Employment Information 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. This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with work‑from‑home flexibility, 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.
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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