Biostatistics Director – Oncology Biosimilars

🕒 il y a 23 jours

🌽 Illinois, New Jersey, +4 états de plus – Distant

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

💵 $200 108 - $270 735 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 1%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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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