Our client is a leader in developing innovative therapies for a variety of cancers. They are seeking a Director of Oncology Biostatistics to provide scientific and statistical leadership for key molecules. A visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance the delivery of crucial medicines to patients.
In this role you will:
· Lead the statistical support for one or more clinical development projects
· Lead/develop statistical strategy for project development and regulatory submissions
· Direct or provide statistical leadership for design, analysis and reporting for clinical or other scientific research
· Lead the development of protocols, statistical analysis plans, and statistical programming plan
· 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
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Please Possess:
· 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