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Senior Manager, Biostatistics

Full-Time Tokyo, Japan
Health & Biotech
Health & Biotech
01 April 2024
  • Collaborates with Clinical Development, Clinical Pharmacology, Regulatory and Clinical Operations expertise areas to design clinical trials.
  • Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts
  • Contributes to or prepares statistical analysis plans and Data Presentation Plans
  • Collaborates with Data Management, Clinical Development, Clinical Pharmacology and Clinical Operations on design of eCRFs
  • Provides statistical guidance on conduct of ongoing trials
  • Collaborates with Statistical Programmers on summary and analysis of trial data. Writes and/or reviews ADS and ad hoc analysis specifications
  • Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
  • Contributes to scientific articles, summarizing data collected in Alexion trials.
  • Participates in other activities and meetings to support Biostatistics and the Global Program Team as needed.
  • Consults with Research & Preclinical colleagues on statistical questions in their work.
  • Manages CRO statistical and programming support.

  • PhD in Biostatistics, Statistics, or equivalent with at least 4 years pharmaceutical biostatistics experience or MS with at least 6 years of relevant experience.
  • Excellent written and oral communication skills
  • Excellent presentation and interpersonal skills
  • Experience programming in SAS
  • Experience with simulations (design, implementation and interpretation)
  • Understanding of ICH GCP as well as general knowledge of industry practices and standards
  • Familiarity with R programming language and other statistical software, including EAST
  • Experience with CDISC, including SDTM, ADaM, CDASH
  • Flexible, well-organized, and possess the ability to work well under pressure.
  • The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.


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