Director, Oncology Biostatistics - California, United States - Penfield Search Partners Ltd

Description

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