Biostatistics Director – Oncology Biosimilars

🕒 Outubro 15

🌽 Illinois, New Jersey, +4 estados a mais – Remoto

🌽 Illinois – Remote 🏖️ New Jersey – Remote 🦀 Maryland – Remote 🔔 Pennsylvania – Remote 🤠 Texas – Remote ☕ Washington – Remote

💵 $200.108 - $270.735 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Provide strategic statistical input for clinical development from early to late phase across multiple products and therapeutic areas • Develop and maintain statistical excellence in the design, analysis, and reporting of biosimilar development • Contribute to clinical development plans • Review clinical development plans, regulatory documents, study synopses, protocols, SAPs, flash memos, CSRs, submission documents, health-authority correspondence, and clinical publications • Hire, allocate, manage, and develop internal statistical staff • Develop and execute statistical strategies for clinical development programs • Ensure standards, technical quality, and consistent approaches in study design and statistical analysis • Provide statistical input into regulatory strategies, presentations, scientific reports, clinical trials, regulatory submissions, product defense, market support, and publications • Represent the statistical function in meetings with regulatory authorities, key opinion leaders, and specialist bodies • Provide oversight and mentorship to Amgen staff and CROs on study deliverables, timelines, and quality standards • Support development and review of policies, SOPs, and controlled documents • Provide subject matter expertise in statistical methodologies • Publish applied research and present statistical methodology at external scientific meetings • Stay current with scientific advances and update internal practices • Develop and maintain relationships with statistical opinion leaders in academia, regulatory agencies, and industry

🎯 Requisitos

• Doctorate degree and 4 years of Biostatistics experience OR Master’s degree and 8 years of Biostatistics experience OR Bachelor’s degree and 10 years of Biostatistics experience • Master’s or Doctorate degree in Mathematics, Biostatistics or Statistics preferred • Ten years post-graduate statistical experience in the pharmaceutical industry or medical research organizations • Deep knowledge of statistical methodology and applications within drug development, especially in oncology • Knowledge of statistical methodology and applications within drug development • Statistical leadership to regulatory submissions • Effective written and oral communication and presentation skills, including statistical strategy • Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designs • Experience with adaptive designs, including group sequential design, treatment arm selection adaptations, Bayesian adaptive design, and/or combined phase 1/2 or phase 2/3 design • Life cycle drug development experience from pre-clinical development through clinical development and post-marketing • Demonstrated leadership attributes and a track record developing high-performance teams • Experience working within a global team and with CRO partners • Ability to work in the U.S. excluding Puerto Rico; sponsorship is not guaranteed

🏖️ Benefícios

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support

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