Senior Principal Biostatistician (R&D)
Biogen
Tokyo, Japan
3 日前

求人内容

日本語必須です JLPT (Japanese Proficient Japanese Test) N1レベル

Applicant MUST have business or higher level Japanese skill (verbal / writing). JLPT (Japanese Proficient Japanese Test) N1 is required.

The Senior Principal Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas in Japan.

He / She develops statistical analysis plans, performs statistical analyses, interprets statistical results, and prepares clinical study reports including integrated summaries for submissions as appropriate in collaboration with Biostatistics, Analytics and Data Sciences (ADS).

He / she also assists in preparation of responses to statistical issues arising in regulatory or other legal settings, or from external development partners in Japan.

He / She maintains liaison with clinical research personnel to identify and meet the statistical support required by the development strategy under the supervision of the Associate Director.

He / She also contributes to the long-term growth strategy of the department by participating in process improvement initiatives, keeping abreast of the current statistical methodology development.

資格

  • MS or PhD in Biostatistics / Statistics or equivalent
  • PhD in Biostatistics / Statistics or equivalent with a minimum of 3-5 years relevant work experience or MS in Biostatistics / Statistics with a minimum of 5-7 years relevant experience
  • Thorough understanding of statistical principles and clinical trial methodology with the abilities to develop statistical / technical solutions in consistent with objectives and to practice and implement them
  • Conversant with SAS or other software programming, and detailed knowledge of SAS procedures as well as computing tools for modelling and simulations
  • Working knowledge of medical / biological terminology and clinical trial designs in relevant therapeutic areas
  • Substantial past regulatory interactions
  • Working knowledge of regulatory guidelines relating to statistical analysis, study reports and statistical components of regulatory submissions
  • Able to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
  • Excellent written and oral communication skills in Japanese and English including being able to explain methodology and consequences of decisions in lay terms
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