Director - Statistical Innovation

September 17

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Amgen

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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