Biostatistics Director

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. Accountabilities Develop, lead, and serve as the primary point of contact for the statistical program strategy for a portfolio of complex programs Influence across product life cycle through developing statistically compelling Evidence Generation Plans (EGP) in collaboration with Strategic Development Director, Director, Statistical Innovation, EDL, GDL, GMAL, and Regional Medical LeadsPartner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support Responsibilities Statistical Excellence Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for productPartner with CfDA Design & Innovation to drive novel designs and fit-for-purpose statistical approaches, standards, technical quality, study design, analysis, interpretation and evidence synthesis in balance with speed, quality, and cost for designated products / programsPartner with Strategic Development Director / Director, Statistical Innovation / EDL / GDL / GMAL / PT to define the data and evidence requirements for product lifecycle and translate it into the EGP as well as other potential applications of innovations (e.g., collaborations with CfOR and HEOR)Oversee creation of Global Statistical Strategic Plan (GSSP) to align program design and statistical approaches with product strategy and EGPOversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listings shells, submission data file specifications, and other key product-related documentationPartner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support for HTAs and payer negotiations, regulatory submissions RTQs, safety and benefit-risk assessment, and scientific publicationsProvide strategic input and be the key biostatistics contact for regulatory queries and interactions with regulatory agencies in collaboration with the Principal StatisticianContribute to statistical strategy with other analytical groups (e.g. PK/PD modelling strategy, biomarker analysis plan) Resource Management Lead global biostatistics teamLead in the achievement of annual department goalsManage and develop staffEnsure Biostatistics team effectively utilize assigned supplier resources Oversee development of Amgen Policies, SOPs and other controlled documents Qualifications Basic Qualifications Doctorate degree and 4 years ofexperience OR Masters degree and 7 years ofexperience OR Bachelors degree and 9 years ofexperience Preferred Qualifications Doctorate in Statistics/Biostatistics and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research, and inflammatory/autoimmune and/or rare disease area of at least 4 years Or Masters degree and 12 years of Biostatistics experiencein the pharmaceutical industry or medical research, and inflammatory/autoimmune and/or rare disease area of at least 4 yearsParticipation in regulatory interactionsStatistical technical and strategic leadership / contribution to regulatory / reimbursement submissionsPeople Management experience Life Cycle Drug Development ExperienceIndependent leadership of multiple projectsExperience working effectively in a globally dispersed team environment with cross-cultural partnersExcellent oral and written communication skillsThorough understanding of regulatory and industry trendsExperience developing policies and SOPsScientific research/publications in one or more areas of statistical science Competencies Scientific / Technical Excellence: Superior understanding of statistical principles, methods, applications, and procedures and can apply innovative study designLeads and instructs others in statistical areas relating to randomized and non-randomized clinical researchExcellent analytical and problem-solving skillsDeep understanding of drug development process and operationsHighly proficient in biostatistical softwareExcellent business acumen and strategic thinking skills People / Project Management : Communicates complex and nuanced statistical information in a concise and impactful wayincluding to lay audiences Successfully leads cross-functional teams across geographies;Excellent organization skillsAble to navigate in a large global, matrixed organizationDemonstrates ability to identify and adapt to shifting priorities and competing demandsManages teams (including external service providers) to tasks and timelines 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. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.