Senior Director, Statistical Innovation

🕒 il y a 27 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 4%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.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 senior advisory input on therapeutic-area and product-development strategies, development programs, and clinical studies • Drive evaluation and selection of conventional and innovative study designs, estimands, and estimators • Advise senior stakeholders on complex statistical and methodological issues affecting development decisions, regulatory interactions, and filings • Synthesize and interpret simulation results, regulatory considerations, operational feasibility, and development objectives • Provide specifications to the Simulation and Modeling team and develop, review, and approve simulation plans and results • Connect insights and lessons across products and programs to promote consistent application of innovative design and analysis approaches • Advise Biostatistics TA leaders, GSLs, and EGTs on product strategy, program design, and clinical study design • Direct, apply, interpret, and communicate modeling and simulation with quantitative partners • Review study design options, proposals, development plans, Phase 2 and Phase 3 protocols, and governance submissions • Build strategic partnerships with biostatistics leaders, strategic development, GSLs, EGT functional leaders, FSC members, and senior stakeholders • Promote innovative designs and analysis methods across products and programs • Sign off the simulation plan • Produce design options for ECP, design simulation plans, design and simulation tools, and detailed study-specific designs

🎯 Exigences

• Doctorate degree and 5 years of Statistics/Biostatistics or related subjects with high statistical content, OR Master’s degree and 9 years, OR Bachelor’s degree and 11 years • At least 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • At least 12 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, execution, analysis and reporting • Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions • Strategic statistical leadership at product level of at least one complex program or multiple programs of moderate complexity • Expertise in statistical principles, methods, and procedures relating to randomized and non-randomized clinical research • Ability to propose and apply innovative study design and advanced statistical methods • Expertise in advanced statistical analysis methods, modeling and simulation • Knowledge of disease areas and regulatory guidelines • Experience leading regulatory and/or reimbursement submissions • Strong oral and written communication skills • Strong influencing and negotiating skills • Excellent business acumen and strategic thinking • Ability to manage multiple projects and prioritize • Ability to lead without direct authority • Ability to navigate a large global organization and build partnerships with FSC and EGT members

🏖️ Avantages

• Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance plans