Director, Statistical Innovation

Found in: beBee jobs US - 2 weeks ago

Washington, Washington, D.C., United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Director, Statistical Innovation (DSI)

Live

What you will do

Lets do this Lets 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 costProvides 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 reviewProvides Technical ExpertiseProvides technical expertise to GSL and EGT on innovative study designs and advanced analytical methodsProvides design options and simulation specifications to the Simulation and Modeling team and develops and approves the simulation plan and resultsInterprets and communicates modeling and simulation results to inform and guide the selection of optimal trial designsProvides guidance and training to the Simulation and Modeling biostatisticians.Builds Cross-functional NetworkDevelops positive relationships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA team approach when interacting with product teamsForms relationships with counterparts in EGTs to help drive the importance of Design consultation throughout the end-to-end clinical development processEstablishes relationships with TA TRC members to ensure alignment in development strategiesPromotes the advancement of innovative designs and analysis methodsBuilds professional network with external peers in innovative designs and analysis methodsPromotes awareness of innovative designs and analysis methods by coordinating and providing internal training sessionsWinWhat 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 OrMasters degree and 8 years of Biostatistics/Statistical experience OrBachelors degree and 10 years of Biostatistics/Statistical experiencePreferred Qualifications:10 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, implementation, analysis and reportingStatistical expertise and leadership across drug development phases, regulatory submissions, and payer interactionsExcellent 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 researchProven experience with both conventional and innovative trial designs (including adaptive and/or Bayesian) in different phases of drug developmentExpertise in advanced statistical analysis methods, modeling and simulationKnowledge of multiple disease areas and related regulatory guidelinesExperience in leading regulatory and/or reimbursement submissionsStrive for innovation and quick adaptation to new industry trendsWell recognized statistical and strategic leadership among statisticians and cross-functional teamsExternal visibility in biostatistics profession (e.g., through industry committees/forums, links to academia)Scientific research/publications in one or more areas of statistical scienceStrong technical and effective communication skillsManagerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesThriveWhat 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 organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply nowfor 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.

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