Director, Oncology Biostatistics – REMOTE

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

 

Related Post