Real World Data Scientist

4日前

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Description 【募集の背景 / Purpose & Scope】 Member of the medical study team, the primary purpose of the Manager is to contribute to the design, analysis, and reporting of clinical trials/observational studies under the supervision of a more senior Statistician. The position can also act as a Methodology Statistician independently validating the execution of routine common statistical technique and identifying situations where novel techniques may be appropriate. The position is expected to complete routine tasks with an appropriate level of independence and in accordance with the project direction and standards. For more complex tasks, the position works under the supervision of a more senior Statistician. 【職務の内容 / Essential Job Responsibilities】 (雇入れ直後) Contributes to the efficient planning, execution and reporting of clinical or observational studies, post hoc, HTA, regional analyses with an appropriate level of independence

  • Is responsible for the quality and timeliness of all statistical deliverables of the assigned tasks

Authors / reviews:
synopsis, protocol, statistical analysis plans (SAP), Case Report Forms (CRF), Data Validation Plans, tables listings and figure (TLF) specifications

  • Performs statistical analyses in accordance with protocol, SAP, good statistical practice, and available regulatory guidelines.
  • Reviews all outputs for validity and completeness. QC inferential statistical analyses.
  • Monitors timelines and progress, leads and organizes review meetings, such as TLF review meetings, and classification meetings.
  • Contributes to clinical study reports, other reports or publications by providing statistical interpretation of the results. Personal development / Collaboration
  • Collaborates with other study team members (e.g. programmer, data manager, clinical study manager, study medical lead) influencing team members from all disciplines on statistical design, analysis and methodology topics
  • Partners and communicates effectively with other Data Science (DS) functions.
  • Develops expertise beyond statistics by researching medical literature, understands clinical, regulatory, and commercial landscape and builds an adequate network with academic, regulators and industry peers
  • Keeps current on statistical methodology and programming skills (変更の範囲) 会社内での全ての業務 【組織 / Organizational Context】 Part of the Data Science Division (DS), Statistical & Real World Data Science (SRS) is a global, diverse, comprehensive and inclusive group of quantitative scientists who design Astellas' asset programs to allow data-driven decision-making. From candidate nomination through to commercialization and in close partnership with the Primary Focus Divisions, Medical Affairs and Early Development, SRS is accountable for all statistical aspects globally Using state-of-the-art methodology and the most innovative approach, SRS generates compelling evidence using clinical trials or real-world data (RWD) to ensure successful and timely regulatory approval, pricing, reimbursement, and patient access.
  • This position reports to a Director, Sr Director or Executive Director.
  • This position is an individual contributor role.
  • This position is a hybrid position.
  • This position is part of Biostatistics, Medical Affairs (MA) statistics, regional Statistics, Methodology & Simulations or Exploratory statistics in SRS and a member of a deliverable team. 【就業環境に関する要件 / Specific Physical or Environmental Requirements】 Need frequent discussion with the agency or investigators in person at JP sites. Discussion is conducted in Japanese language. 【応募要件 / Qualifications】 PhD in Biostatistics, Statistics/related scientific field with internship experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or M.
S in Biostatistics, Statistics/ related scientific field with 3+ years of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry Good knowledge and skills in SAS required, knowledge of R preferred Language skill:
English in business TOEIC> 730, Japanese writing/talking in fluent

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