Posted to MedZilla on 5/26/2017

Takeda Pharmaceuticals

US-MA, Senior Director, CNE/CEI/Phase I Statistics Head 1603215-MZ



  • Support all aligned TA development projects and marketed products and maximize statistical contributions to clinical, regulatory, and commercial development strategies
  • Promote efficient innovative designs and optimal development plan
  • Contribute to strategies for statistics related technologies, processes, and standards
  • Provide insight and continual research into future direction of statistics


  • Lead development of short and long-range strategies and goals for the aligned TA statistics group with multiple sub-TAs
  • Partner with aligned functional TA heads to maximize statistical contributions to clinical, regulatory, and commercial development strategies
  • Ensure adequate statistical support for all aligned TA development projects and timely delivery of statistical deliverables
  • Oversee aligned TA statistics resource needs
  • Develop and retain statistical talents in the group
  • Ensure productive collaborations with other functions in the aligned TA development organization and with other statistics TA heads
  • Promote innovative designs and efficient analysis methodologies in clinical trials
  • Provide statistical advice and consultation to aligned TA development management
  • Keep the group current on statistical methodologies relating to drug development and regulatory requirements
  • Build and maintain a good network with statistical experts



  • PhD or MS in Statistics or Biostatistics
  • 12+ years of pharmaceutical/biotech experiences with a PhD degree and 15+ years with an MS degree
  • Excellent technical skills
  • Good knowledge of statistical methodologies for aligned TA clinical trials
  • Outstanding communication skills
  • Strong leadership and influencing skills
  • Interact effectively with regulatory authorities
  • NDA/BLA filing experience
  • Ability to influence others, at all levels of the organization, without direct hierarchical authority, and affect change across organizational boundaries.
  • Ability to collaborate effectively with peers, within global teams and in communicating with senior leadership.
  • Must be a strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way.

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