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Director, Oncology Biostatistics - REMOTE

Company: Penfield Search Partners Ltd
Location: San Jose
Posted on: November 25, 2022

Job 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 -

Keywords: Penfield Search Partners Ltd, San Jose , Director, Oncology Biostatistics - REMOTE, Executive , San Jose, California

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