Amgen
Biologics • Human therapeutics • Development of novel products
10,000+
💰 Post-IPO Debt on 2022-12
Director - Statistical Innovation
September 17
Amgen
Biologics • Human therapeutics • Development of novel products
10,000+
💰 Post-IPO Debt on 2022-12
Description
• Critical expertise and leadership in the design and planning of innovative development programs and clinical trials • Guides Product Strategy and Study Design • Gives advisory input in developing the Global Statistical Strategic Plan (GSSP) • Reviews key phase 2 and 3 protocols and provides input • Provides technical expertise on innovative study designs and advanced analytical methods • Interprets and communicates modeling and simulation results to inform optimal trial designs • Builds positive relationships and promotes the importance of design consultation throughout the clinical development process • Establishes professional network with external peers and promotes awareness of innovative designs
Requirements
• Doctorate degree and 4 years of Biostatistics/Statistical experience • Or Master’s degree and 8 years of Biostatistics/Statistical experience • Or Bachelor’s degree and 10 years of Biostatistics/Statistical experience • 10 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, implementation, analysis and reporting • Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions • Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc. • Proven experience with both conventional and innovative trial designs (including adaptive and/or Bayesian) in different phases of drug development • Expertise in advanced statistical analysis methods, modeling and simulation • Knowledge of multiple disease areas and related regulatory guidelines • Experience in leading regulatory and/or reimbursement submissions • Strong technical and effective communication skills • Managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Benefits
• Vast opportunities to learn and move up and across our global organization • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
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