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Director of Biostatistics and Oncology Leadership

2 months ago

Reston, Virginia, United States Penfield Search Partners Ltd Full time
Job Description

**About the Role**

We are seeking a highly skilled and experienced Director of Biostatistics and Oncology Leadership to join our team at Penfield Search Partners Ltd. As a key member of our organization, you will play a critical role in providing scientific and statistical leadership for key molecules in oncology.

Key Responsibilities

  • Lead the statistical support for one or more clinical development projects, ensuring timely and accurate delivery of results.
  • Develop and implement statistical strategies for project development and regulatory submissions, ensuring compliance with relevant regulations and guidelines.
  • Direct or provide statistical leadership for design, analysis, and reporting for clinical or other scientific research, ensuring high-quality results and effective communication with stakeholders.
  • Develop and lead the development of protocols, statistical analysis plans, and statistical programming plans, ensuring alignment with company goals and objectives.
  • Provide statistical input to compound/drug development and drive alignment with functional management, ensuring effective collaboration and communication.
  • Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies, ensuring a comprehensive and integrated approach.
  • Demonstrate extensive understanding of statistical concepts and methodology, staying up-to-date with the latest developments and advancements in the field.
  • Propose novel statistical methodological approaches to design of scientific studies, driving innovation and improvement in our research and development processes.
  • Train and mentor staff on statistical methodology and operations, ensuring effective knowledge transfer and skill development.
  • May supervise contract statisticians or junior Statisticians, providing guidance and support to ensure successful project delivery.
  • Gain expertise in innovative statistical methods, staying ahead of the curve in terms of industry trends and best practices.
  • Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff, ensuring a strong and skilled team.
  • Develop strategy for data presentation and inference, ensuring effective communication of results to stakeholders.
  • Collaborate in publication of scientific research, ensuring that our findings are shared with the broader scientific community.
  • 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, ensuring effective communication and resolution of issues.
  • Build external scientific connections which foster professional development and promote the reputation of the Statistics department, ensuring a strong and respected presence in the industry.
  • Ensure that all applicable regulatory requirements for work processes are met, ensuring compliance with relevant regulations and guidelines.
  • Critically review regulatory submission documents, ensuring accuracy and completeness.
  • Represent department in discussions with regulatory agencies, ensuring effective communication and resolution of issues.

Requirements

  • PhD (with 8+ years of experience) in Statistics or Biostatistics, with a strong background in oncology and 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 relationships 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 overseas teams.
  • Ability to interact effectively with Key Stakeholders, including Clinical development experts, Statistical programmers, Data science experts, Global Medical Affairs experts, and Regulatory experts.