Director, Statistical Innovation Job at Amgen

Job Description

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Job Responsibility

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
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
Builds Cross-functional Network
Develops positive relationships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA ‘team’ approach when interacting with product teams
Forms relationships with counterparts in EGTs to help drive the importance of Design consultation throughout the end-to-end clinical development process
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
Master’s degree and 8 years of Biostatistics/Statistical experience
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.
Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research
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
Strive for innovation and quick adaptation to new industry trends
Well recognized statistical and strategic leadership among statisticians and cross-functional teams
External visibility in biostatistics profession (e.g., through industry committees/forums, links to academia)
Scientific research/publications in one or more areas of statistical science
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

What we offer

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

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Director, Statistical Innovation

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