Director, Statistical Innovation

** 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.

** Director, Statistical Innovation (DSI)*
* ** What you will do*
* Let's do this! Let's change the world. In this vital role you will critical expertise and leadership in the design and planning of innovative development programs and clinical trials.

** Responsibilities:*
* 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

** What we expect of you*
* We are all different, yet we all use our unique contributions to serve patients. The director we seek has these qualifications.

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* Basic Qualifications:

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* + 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

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* Preferred Qualifications:

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* + 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, Win Bugs, 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…