Director, Statistical Innovation

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November 26

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Amgen

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Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

📋 Description

• Guides Product Strategy and Study Design • Promotes innovative design options and fit-for-purpose analysis approaches that address appropriate clinical questions in protocol / program design and balance speed, quality, and cost • Provides advisory input in the development of the Global Statistical Strategic Plan (GSSP) to align study design and statistical approaches with product strategy and Evidence Generation Plan (EGP) • Reviews key phase 2 and 3 protocols and provides input during the TA TRC review • Provides technical expertise to GSL and EGT on innovative study designs and advanced analytical methods • Provides design options and simulation specifications to the Simulation and Modeling team and develops and approves the simulation plan and results • Interprets and communicates modeling and simulation results to inform and guide the selection of optimal trial designs • Provides guidance and training to the Simulation and Modeling biostatisticians • Develops positive relationships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA ‘team’ approach when interacting with product teams • Establishes relationships with TA TRC members to ensure alignment in development strategies • Promotes the advancement of innovative designs and analysis methods • Builds professional network with external peers in innovative designs and analysis methods • Promotes awareness of innovative designs and analysis methods by coordinating and providing internal training sessions

🎯 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 • Managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

🏖️ Benefits

• 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, and flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible