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