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Biostatistics Director

Company: Astellas
Location: Northbrook
Posted on: May 28, 2023

Job Description:

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope:The Biostatistics Director is a very senior biostatistician who provides technical statistical leadership to the biostatistics function and has a major influence on the technical capabilities of the department. May act as a global statistical lead, representing Data Science in Core Teams (CMT or Development Core Team). Responsible for multiple projects, the Biostatistics Director works on the most complex or critical projects, discusses TA strategy, supports interactions with regulatory authorities and key opinion leaders, and is accountable for the statistical soundness of all statistical input and deliverables for the assigned projects. Provides consultancy to other project teams and other statistical leads and advises staff on available statistical methodologies and their application in drug development ensuring the department stays at the forefront of statistical methodologies in drug development. Essential Job Responsibilities:Technical ExcellenceStays at the cutting edge of methodology development in statistics, regulatory guidelines, and industry trends in drug development, particularly with respect to the therapeutic area(s) of interest, and signals relevant developments in a timely manner for the company.Advises project teams and statistical leads on challenging statistical design, analysis and decision-making issues. Provides expert opinions, advises staff on available statistical methodologies, performs/supervises modeling and simulations, and leverages external experts to provide help to clinical development issues.Provides expert statistical strategy input to Core Teams (CMT or Development Core Team) and performs expert review of major deliverablesFacilitates and oversees creation of TA standards with respect to key variables, definitions, statistical methods, data structures and presentation of dataProvides oversight on statistical matters for meetings with regulatory authorities, key opinion leaders and similar experts and bodiesParticipates in reviewing in-licensing opportunities and due diligence activities, reviews data and advises companyStrategyParticipates in development of 1 - 3 year statistics-specific objectives and plansDevelops and implements plans to achieve objectivesLeadership & People DevelopmentReviews key project level documents and advises other statisticians on design and methodologiesAdvises staff on available statistical methodologies and their application in drug developmentCoaches and supports statistical leads in providing best in class data science support to Astellas drug development programsAssists with recruitment, development / career management and retention of staffInspires and advises individuals in investigating and applying advanced statistical methods in drug development programsStrategic thinker and problem solver, who recognizes, anticipates and solves problems; helps individuals to develop problem solving skills. Must be able to delve into high degree of detail when necessaryCollaborationsLeader or member of external industry or professional organizations. Develops and maintains relationships with leading academic institutions and key statistical opinion leadersActively participates in professional association activities to support the branding of AstellasAbility to influence peers in same function, also in other sitesAbility to influence other peers and more senior managers inside and outside of Data Science on best practice in their area of competenceProcess DevelopmentContribute to improvement efforts, implements agreed improvement actions and monitors effects after implementationContribute to development and implementation of best-in-class standards, processes and SOPs in statisticsLeads strategic improvement projectsPerformance and Resource ManagementMeasures and monitors performance standards in collaboration with functional managementContributes to the design of an integrated information technology platform for Data Science, especially in the area of analysis, reporting and data review tools, and database integrationWhen assigned as a statistical lead for clinical development programs and/or lifecycle management of marketed productsProvides statistical advice to clinical teams including design of studies and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may impact the statistical integrity of the development program or for which statistical tools may add value.Ensures that Data Science needs are reflected within the plan and strategy across regions. Ensures quality and consistency of key data science deliverables across studies.Represents the company on statistical matters at meetings with regulatory authorities, key opinion leaders and similar experts /bodiesReviews key project and study documents to ensure optimal statistical presentation and compliance.For studies within assigned projects provides all required statistical support and deliverables by supervising assigned study statisticians.Ensures appropriate vendor oversight for assigned programs when statistical support or programming for studies or other deliverables within assigned projects are contracted out to a CRO.Quantitative Dimensions:The Data Science department provides statistical, biometrical and data management/warehousing expertise for all R&D projects and marketed products, encompassing Phase I-IV studies. Qualified biostatistical expertise for clinical studies and drug submissions is a regulatory requirement and carried out in accordance with international regulations (ICH, FDA, PMDA, EMA) and internal Astellas SOPs and standards. The results must be reproducible and statistically sound and are subject to internal and external inspections. Flawed statistical input to drug development projects may result in failure to achieve marketing authorization or regulatory approval delays resulting in substantial financial loss for the company.A Biostatistics Director makes decisions and recommendations that could affect the methodology used across many of Astellas projects. He/she undertakes this work with full independence. Organizational Context:This position reports to the Primary Focus Biostatistics Lead (ED level) or Senior Biostatistics Director. As a member of project teams, leads the data science extended (project) team and deliverables teams. Manages to achieve successful outcome through delegation of work, coaches assigned team members within own functions. Provides guidance to / mentors less experienced statisticians.PDN-990b160a-c836-4dd3-a8a6-afa5460c6d60

Keywords: Astellas, Chicago , Biostatistics Director, Executive , Northbrook, Illinois

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