IDEAYA Biosciences
Senior Director, Biostatistics
IDEAYA Biosciences, South San Francisco, California, us, 94083
Overview
Join to apply for the Senior Director, Biostatistics role at IDEAYA Biosciences. Location: South San Francisco, CA. IDEAYA is a precision medicine oncology company focused on discovery, development, and commercialization of transformative therapies for cancer. The company operates in small-molecule drug discovery, structural biology, and bioinformatics with internal capabilities in identifying and validating translational biomarkers for tailored therapies. For more information, please see www.ideayabio.com. Position 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 for the development of IDEAYA therapeutics in collaboration with Clinical Development, Regulatory Affairs, Drug Safety, Clinical Pharmacology, Data Management, Translational Development and Program Management. The role contributes to Clinical Development Plans, including the creation and execution of clinical protocols and statistical analysis plans (SAPs), regulatory submissions, and publications. It will oversee the IDEAYA biostatistics team (internal and external) to ensure high-quality, timely deliverables, and will act as the statistical representative in defending the company position on statistical issues and drug approvals globally. This role has significant stakeholder management responsibilities with business partners. The biostatistician leader is responsible for driving optimal study designs, data collection, analytic approaches, and rigorous interpretation of data. The person will interact with external vendors, key opinion leaders and regulatory agencies. Reporting to: Senior Director, Biostatistics. What you’ll do
Lead the Biometrics team in cross-functional IDEAYA teams. Provide strategic input to 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, publications, and other study-level documents. Manage and/or oversee biostatistical teams on responsible drug development programs, including personnel, programmers, consultants, and vendors to produce statistical software and high-quality TFLs. Act as a resource and mentor to development teams; translate scientific questions into statistical terms and communicate statistical concepts clearly; challenge assumptions and enforce rigorous methodologies. Assess, provide direction, 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 R&D. Hands-on experience writing complex protocols and SAPs and performing interim and CSR analyses in oncology clinical development 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 deep experience in time-to-event analyses. Strong leadership and ability to work in cross-functional teams, with excellent interpersonal, communication, writing, and organizational skills. Total Rewards
IDEAYA offers a competitive total rewards package including merit-based salary reviews, discretionary short-term incentive plan participation, and discretionary stock option awards (board approval). Benefits include medical/dental/vision coverage, 401k, ESPP, and wellness programs. The expected salary range is $295,000 – $310,000. Final salary will depend on factors including location, experience, disease area experience, education, and interview performance. Additional Information
The company complies with equal employment opportunity laws and does not discriminate based on protected characteristics. This position requires onsite work at IDEAYA facilities with some work-from-home flexibility. A COVID-19 vaccination is required unless a reasonable accommodation is provided by law. The company considers you fully vaccinated after 14 days from the final vaccine dose, with vaccines approved by FDA or WHO-listed. IDEAYA is an equal opportunity employer. EOE/AA/Vets. Job Details and Nearby Roles
Seniority level: Director Employment type: Full-time Job function: Research, Analyst, and Information Technology
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Join to apply for the Senior Director, Biostatistics role at IDEAYA Biosciences. Location: South San Francisco, CA. IDEAYA is a precision medicine oncology company focused on discovery, development, and commercialization of transformative therapies for cancer. The company operates in small-molecule drug discovery, structural biology, and bioinformatics with internal capabilities in identifying and validating translational biomarkers for tailored therapies. For more information, please see www.ideayabio.com. Position 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 for the development of IDEAYA therapeutics in collaboration with Clinical Development, Regulatory Affairs, Drug Safety, Clinical Pharmacology, Data Management, Translational Development and Program Management. The role contributes to Clinical Development Plans, including the creation and execution of clinical protocols and statistical analysis plans (SAPs), regulatory submissions, and publications. It will oversee the IDEAYA biostatistics team (internal and external) to ensure high-quality, timely deliverables, and will act as the statistical representative in defending the company position on statistical issues and drug approvals globally. This role has significant stakeholder management responsibilities with business partners. The biostatistician leader is responsible for driving optimal study designs, data collection, analytic approaches, and rigorous interpretation of data. The person will interact with external vendors, key opinion leaders and regulatory agencies. Reporting to: Senior Director, Biostatistics. What you’ll do
Lead the Biometrics team in cross-functional IDEAYA teams. Provide strategic input to 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, publications, and other study-level documents. Manage and/or oversee biostatistical teams on responsible drug development programs, including personnel, programmers, consultants, and vendors to produce statistical software and high-quality TFLs. Act as a resource and mentor to development teams; translate scientific questions into statistical terms and communicate statistical concepts clearly; challenge assumptions and enforce rigorous methodologies. Assess, provide direction, 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 R&D. Hands-on experience writing complex protocols and SAPs and performing interim and CSR analyses in oncology clinical development 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 deep experience in time-to-event analyses. Strong leadership and ability to work in cross-functional teams, with excellent interpersonal, communication, writing, and organizational skills. Total Rewards
IDEAYA offers a competitive total rewards package including merit-based salary reviews, discretionary short-term incentive plan participation, and discretionary stock option awards (board approval). Benefits include medical/dental/vision coverage, 401k, ESPP, and wellness programs. The expected salary range is $295,000 – $310,000. Final salary will depend on factors including location, experience, disease area experience, education, and interview performance. Additional Information
The company complies with equal employment opportunity laws and does not discriminate based on protected characteristics. This position requires onsite work at IDEAYA facilities with some work-from-home flexibility. A COVID-19 vaccination is required unless a reasonable accommodation is provided by law. The company considers you fully vaccinated after 14 days from the final vaccine dose, with vaccines approved by FDA or WHO-listed. IDEAYA is an equal opportunity employer. EOE/AA/Vets. Job Details and Nearby Roles
Seniority level: Director Employment type: Full-time Job function: Research, Analyst, and Information Technology
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