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| Associate Biostatistics Director IL Open (J#45290) Title: Associate Biostatistics Director Company: Astellas Pharma US Description Astellas is dedicated to becoming a global leader in the area of oncology. We have been able to establish a strong pipeline through our internal research efforts, in-licensing opportunities, and acquisitions, all of which will lead to great things for the future of Astellas. We understand that this will require a talented workforce that has focused on oncology in their past experiences, and share our desire to improve the lives of those suffering from cancer. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can truly make a difference.Astellas is announcing an Associate Biostatistics Director opportunity at our Deerfield, IL location.The Associate Biostatistics Director acts as fully independent global statistical lead (GSTATL), representing Data Science in Core Teams. He/she may be responsible for one or for multiple global or local drug projects within the same indication / therapeutic area. He/she leads large and/or complex projects, interacts with regulatory authorities and key opinion leaders, supervises other statisticians providing support to the projects 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 GSTATLs in areas of expertise. He/she is expected to complete these tasks with very minimal supervision, appropriately and pro-actively seeking line management intervention where needed to ensure successful outcome, e.g. with respect to project resource requirements or key strategic functional issues.Participates in project teams for clinical development programs and/or lifecycle management of marketed productsProvides strategic statistical input to the project teams and is a major contributor to the clinical development plan (CDP). Ensures CDP with statistical integrity and optimal study designs, and ensures that Data Science needs are reflected within the development plan and strategy across regions. Provides statistical advice to clinical teams including design of studies and analyses requiring advanced statistical methodologies. Recognises and addresses issues which may impact the statistical integrity of the development program or for which statistical tools may add value.Provides best in class data science support to Astellas drug development programs and leads the Data Science extended (project) team and deliverables teams. Ensures quality and consistency of key data science deliverables across studies. Ensures creation of, maintenance and adherence to indication specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results.Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.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. These documents include, but are not limited to, clinical development plans (CDPs), protocols, analysis plans, study reports, submission documents and correspondence with health authorities.For studies within assigned projectsProvides all required statistical support and deliverables by supervising another statistician in that role, or as a member of study team him/herself.Writes or reviews key study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, protocols, analysis plans, tables, listings, and figure (TLF) specifications, study reports.Ensures efficient planning, execution and reporting of clinical studies and statistical review of critical documents such as CRFs, Data Validation Plans, SDTM/ADaM data specifications, TLFsEnsures statistical analyses performed in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines. More... | |||
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