Coordinates, provides and delivers methodological and statistical expertise and/or statistical analyses for clinical studies in EPD. In this matter supports both the Clinical Development portfolio as well as Strategic Medical Affairs in their support to Affiliates, thereby complying with international, regulatory guidelines and EPD policies and standards. Directs the operational aspects of statistical work as outsourced to CROs
Requirements:
MSc./PhD in Statistics, or Biostatistics, or a related field; Demonstrated high competence in experimental design and statistical inference. Thorough understanding of International Conference on Harmonization (ICH) Guideline and relevant regulatory requirements (e.g., EU, US, or China). Minimum 7 years experience as Statistician in pharmaceutical industry or CRO
Text:
Principal Statistician Coordinates, provides and delivers methodological and statistical expertise and/or statistical analyses for clinical studies in EPD. In this matter supports both the Clinical Development portfolio as well as Strategic Medical Affairs in their support to Affiliates, thereby complying with international, regulatory guidelines and EPD policies and standards. Directs the operational aspects of statistical work as outsourced to CROs MSc./PhD in Statistics, or Biostatistics, or a related field; Demonstrated high competence in experimental design and statistical inference. Thorough understanding of International Conference on Harmonization (ICH) Guideline and relevant regulatory requirements (e.g., EU, US, or China). Minimum 7 years experience as Statistician in pharmaceutical industry or CRO
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