Job Details
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
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