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Director, Statistics, Delivery and Strategy

Company: Takeda
Location: Cambridge
Posted on: February 19, 2021

Job Description:

OBJECTIVES

  • Lead and manage a team of statisticians in a subgroup within a TA. Support all development projects assigned to his or her team and maximize statistical contributions to clinical, regulatory, and commercial development strategies
  • Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, interpretations, regulatory submissions and follow up.
  • Promote efficient innovative designs and optimal development plan
  • Contribute to strategies for statistics related technologies, processes, and standardsACCOUNTABILITIES:
    • Ensure adequate statistical support for development projects in the group and timely delivery of statistical deliverables
    • Oversee aligned statistics resource needs
    • Develop and retain statistical talents in the group
    • Ensure productive collaborations with other functions and other groups
    • Promote innovative designs and efficient analysis methodologies in clinical trials
    • Provide statistical advice and consultation to development teams
    • Keep the group current on statistical methodologies relating to drug development and regulatory requirements
    • Build and maintain a good network with external statistical expertsEDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:
      • PhD in Statistics or Biostatistics and 10+ years of pharmaceutical/biotech experiences with a PhD 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.
      • Experience in innovative use of RWE in clinical development or totality of evidence approach in regulatory submissions preferred
      • Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries.
      • Inspires and motivates the group. Takes stand on important issues in productive and respectful way.

Keywords: Takeda, Cambridge , Director, Statistics, Delivery and Strategy, Executive , Cambridge, Massachusetts

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