Director of Biostatistics and Oncology

7 hours ago


Reston, Virginia, United States Penfield Search Partners Ltd Full time
Director of Oncology Biostatistics

At Penfield Search Partners Ltd, we are seeking a highly skilled Director of Oncology Biostatistics to join our team. As a key member of our organization, you will provide scientific and statistical leadership for key molecules, working in partnership with clinical and regulatory experts to advance the delivery of crucial medicines to patients.

Key Responsibilities:

  • Lead the statistical support for one or more clinical development projects
  • Develop and lead statistical strategy for project development and regulatory submissions
  • Direct or provide statistical leadership for design, analysis, and reporting for clinical or other scientific research
  • Develop protocols, statistical analysis plans, and statistical programming plans
  • Provide statistical input to compound/drug development and drive alignment with functional management
  • Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies
  • Demonstrate extensive understanding of statistical concepts and methodology
  • Propose novel statistical methodological approaches to design of scientific studies
  • Train and mentor staff on statistical methodology and operations
  • May supervise contract statisticians or junior Statisticians
  • Gain expertise in innovative statistical methods
  • Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff
  • Develop strategy for data presentation and inference
  • Collaborate in publication of scientific research
  • Act as the liaison for statistical issues on collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities
  • Build external scientific connections which foster professional development and promote the reputation of the Statistics department
  • Ensure that all applicable regulatory requirements for work processes are met
  • Critically review regulatory submission documents
  • Represent department in discussions with regulatory agencies

Requirements:

  • PhD (with 8+ years of experience) in Statistics or Biostatistics
  • Ability to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others
  • Ability to build strong relationship with peers and cross-functional partners to achieve higher performance
  • Be highly motivated to drive innovation by raising the bar and challenging the status quo
  • Strong leadership skills and experience in managing cross-cultural or oversea teams
  • Ability to interact effectively with Key Stakeholders:
    • Clinical development experts
    • Statistical programmers
    • Data science experts
    • Global Medical Affairs experts
    • Regulatory experts


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