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Overview
Senior Director, Biostatistics at IDEAYA Biosciences. Location: South San Francisco, CA. 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. Job Summary
We are seeking a Senior Director, Biostatistics to join IDEAYA’s Biometrics department. The Senior Director, Biostatistics will lead Biostatistics and Biometrics at IDEAYA and oversee 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. Responsible for contributing to Clinical Development Plans, including creation and execution of clinical protocols and statistical analysis plans (SAPs), as well as regulatory submissions and publications. Oversees the IDEAYA biostatistics team (internal and external) to ensure high quality and timely deliverables. Serves as the statistical representative in defense of the company position on statistical issues and drug approvals globally. Significant stakeholder management with business partners. Drives optimal study designs, data collection, analytic approaches, and rigorous interpretation of data. Interacts with external vendors, key opinion leaders and regulatory agencies. Reporting to: Senior Director, Biostatistics. 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, in coordination with each 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, including all biostatistics personnel, programmers, consultants, and vendors to produce statistical software and generate high quality TFLs. Act as a resource and mentor to development teams; translate scientific questions into statistical terms and vice versa; challenge 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. Requirements
Ph.D. or M.S. in Statistics or 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. Hands-on experience writing complex protocols and SAPs and performing interim and CSR analyses in oncology clinical development lifecycle from Phase 1 to regulatory submission. Direct involvement 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 of time-to-event analysis. Strong leadership with ability to work in a cross-functional team; excellent interpersonal, communication, writing, and organizational skills. Total Rewards
IDEAYA offers a competitive total rewards package including merit-based salary increases, discretionary short-term incentive plan participation, and discretionary stock option awards (board approval). Benefits include medical/dental/vision coverage (100% company paid for employees and 90% for dependents), 401k, ESPP, and wellness programs. The expected salary range for the role of Senior Director, Biostatistics is $295,000 - $310,000. Final salary depends on location, experience, disease area experience, education, and interview performance. The Company complies with all laws respecting equal employment opportunities and does not discriminate on protected characteristics. This position requires onsite work at the Company’s facilities with work-from-home flexibility; all employees in facilities must be fully vaccinated against COVID-19, with reasonable accommodations as required by law. IDEAYA is an equal opportunity employer. EOE/AA/Vets. Employment details
Seniority level: Director Employment type: Full-time Job function: Research, Analyst, and Information Technology
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Senior Director, Biostatistics at IDEAYA Biosciences. Location: South San Francisco, CA. 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. Job Summary
We are seeking a Senior Director, Biostatistics to join IDEAYA’s Biometrics department. The Senior Director, Biostatistics will lead Biostatistics and Biometrics at IDEAYA and oversee 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. Responsible for contributing to Clinical Development Plans, including creation and execution of clinical protocols and statistical analysis plans (SAPs), as well as regulatory submissions and publications. Oversees the IDEAYA biostatistics team (internal and external) to ensure high quality and timely deliverables. Serves as the statistical representative in defense of the company position on statistical issues and drug approvals globally. Significant stakeholder management with business partners. Drives optimal study designs, data collection, analytic approaches, and rigorous interpretation of data. Interacts with external vendors, key opinion leaders and regulatory agencies. Reporting to: Senior Director, Biostatistics. 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, in coordination with each 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, including all biostatistics personnel, programmers, consultants, and vendors to produce statistical software and generate high quality TFLs. Act as a resource and mentor to development teams; translate scientific questions into statistical terms and vice versa; challenge 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. Requirements
Ph.D. or M.S. in Statistics or 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. Hands-on experience writing complex protocols and SAPs and performing interim and CSR analyses in oncology clinical development lifecycle from Phase 1 to regulatory submission. Direct involvement 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 of time-to-event analysis. Strong leadership with ability to work in a cross-functional team; excellent interpersonal, communication, writing, and organizational skills. Total Rewards
IDEAYA offers a competitive total rewards package including merit-based salary increases, discretionary short-term incentive plan participation, and discretionary stock option awards (board approval). Benefits include medical/dental/vision coverage (100% company paid for employees and 90% for dependents), 401k, ESPP, and wellness programs. The expected salary range for the role of Senior Director, Biostatistics is $295,000 - $310,000. Final salary depends on location, experience, disease area experience, education, and interview performance. The Company complies with all laws respecting equal employment opportunities and does not discriminate on protected characteristics. This position requires onsite work at the Company’s facilities with work-from-home flexibility; all employees in facilities must be fully vaccinated against COVID-19, with reasonable accommodations as required by law. IDEAYA is an equal opportunity employer. EOE/AA/Vets. Employment details
Seniority level: Director Employment type: Full-time Job function: Research, Analyst, and Information Technology
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