Description
**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
**Director, Statistical Innovation (DSI)**
**Live**
**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.
**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
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The director we seek is a [type of person] with these qualifications.
**Basic Qualifications:**
+ 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
**Preferred Qualifications:**
+ 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
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
+ 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
**Apply now**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
