Senior Director, Safety Biostatistics
$270,000–$334,000 year
On-siteSouth San Francisco, California, United States
Job Summary
Lead the biometrics team and provide strategic statistical support for IDEAYA's oncology therapeutics, driving optimal study designs and rigorous data interpretation. Oversee the development of clinical protocols, statistical analysis plans, and regulatory documents including IBs, DSURs, and submissions, while managing internal and external vendors. Serve as the statistical representative in global defense of the company's approach on statistical issues and drug approvals, acting as a resource to translate scientific questions into statistical terms for cross-functional teams. Maintain high standards for quality delivery and mentor development teams to ensure timely, high-quality deliverables across the clinical development lifecycle.
Required Qualifications
- Ph.D. or M.S. in Statistics or closely related field
- 15+ years statistical experience in drug development
- at least 10 years in oncology drug development
- 8 years extensive experience in supporting Drug Safety and Pharmacovigilance in pharmaceutical industry R&D
- Extensive hands-on experience from writing complex protocols and SAPs to performing interim and CSR analyses in oncology clinical development lifecycle from Phase 1 study to regulatory submission
- Direct involvement and responsibility and hands-on experience in multiple NDA/BLA submissions with track records of approval of oncology drugs
- Expert knowledge of clinical trial design concepts and statistical methodologies with in-depth understanding in safety analysis
- Demonstrated strong ability and leadership to work in a cross-functional team environment with good interpersonal, communication, writing and organizational skills
- Act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA's Code of Conduct
- Demonstrate good judgement and ethical behavior in all business activities
- Maintain patient and product safety as a top priority
- Report any suspected violations of law or Company policy through appropriate channels
- Work onsite in the office at the Company's facilities for training & meetings
- Be fully vaccinated from COVID-19
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