Senior Director, Biostatistics

🕒 il y a 11 jours

🇺🇸 États-Unis – Télétravail

💵 $223 624 - $302 551 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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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 to and oversee all statistical aspects of biosimilar development for all products • Lead, manage, and develop the biosimilars biostatistics team • Oversee the performance of biostatisticians in Contract Research Organizations (CROs) • Enhance statistical understanding within Biosimilar Development • Develop innovative methodologies and study designs for biosimilars • Assist the head of Biostatistics and Statistical Programming in leading the department • Provide oversight for protocols, Statistical Analysis Plans, Flash Memos/Summary of Report, Clinical Study Reports, submission documents, health-authority correspondence, clinical publications, reimbursement documents, and other communications • Contribute strategic statistical input to clinical development plans • Ensure standards, technical quality, and consistent approaches in clinical development strategy, study design, statistical analysis, data structures, and results presentation • Provide statistical input into regulatory strategies, presentations, scientific reports, clinical trial submissions, product defense, market support, and scientific publications • Represent Biosimilar Development on statistical matters with regulatory authorities, key opinion leaders, and expert bodies • Provide oversight and guidance to Amgen and CRO staff on study deliverables, timelines, and quality standards • Hire, allocate, manage, and develop internal statistical staff; contribute to goals, budgets, and resource plans • Lead or participate in developing and reviewing Policies, SOPs, and controlled documents • Promote and communicate statistical methodologies; publish applied research and present at external scientific meetings • Maintain relationships with academic, regulatory, and industry statistical opinion leaders

🎯 Exigences

• Doctorate degree and 5 years of Senior Director, Biostatistics experience; OR Master’s degree and 9 years of Senior Director, Biostatistics experience; OR Bachelor’s degree and 11 years of Senior Director, Biostatistics experience • At least 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation • Established records of strong leadership and people management skills • Statistical leadership to regulatory submissions, including advisory committees • Demonstrated effective written and oral communication skills, including statistical strategy • Doctorate in Statistics/Biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research, or Master’s degree in Statistics/Biostatistics and at least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research • Ten years of post-graduate statistical experience in the pharmaceutical industry • Ability to work within a global team and with CRO partners • Life-cycle drug development experience spanning pre-clinical development, clinical development, and post-marketing • Knowledge/experience of biosimilars development, including global regulatory requirements and design and analysis of non-inferiority and equivalence trials