Vice President, Biostatistics
$360,000–$418,000 year
On-siteAlameda, California, United States
Job Summary
Lead the development and oversight of biostatistics, tool strategies, and operations to ensure efficient, accurate, and timely clinical trial data collection and analysis while maintaining high data integrity standards. Develop and implement company policies and procedures in compliance with industry standards to optimize compliance, effectiveness, and efficiency. Collaborate with product development teams to establish drug development strategy and direction, and interact with executive leadership to manage risk and influence long-term departmental viability. Work with project clinicians to design, develop, and analyze Phase I–IV clinical protocols and statistical analysis plans, identifying statistical methods for regulatory and publication purposes. Provide executive leadership for sponsor/CRO activities and interact with FDA and regulatory authorities to ensure studies meet requirements. Oversee best practices, SOPs, and policies for biostatistics tools, manage key opinion leaders, academic relationships, and vendors, and set up the statistical science team. Directly supervise employees and manage departmental budgets within corporate fiscal targets.
Required Qualifications
- BA/BS in related discipline
- MA/MS in related discipline
- PhD in related discipline
- Equivalent combination of education and experience
- Minimum of twenty-one years of relevant experience in the pharmaceutical industry
- Minimum of nineteen years of relevant experience in the pharmaceutical industry
- Minimum of seventeen years of relevant experience in the pharmaceutical industry
- At least 15 years progressive experience in biostatistics
- At least 8 years of progressive functional area management background
- At least senior director level
- Thorough understanding of the biostatistics functional areas in the therapeutic area of oncology
- Thorough understanding of the pharmaceutical industry or clinical trials unit setting
- Successful track record of the management of clinical studies, from Phase I – III in support of US NDA filings
- Proven ability to translate strategy into implementation that leads to results
- Strong track record of performance excellence meeting milestones and objectives
- The ability to articulate a vision and strategy in a way that inspires and motivates teams to achieve results
- Demonstrated success in collaborating and interfacing effectively with executives, advisory committees (Internal, external, and regulatory), peers, subordinates, project teams, etc., throughout the organization
- Proven ability to deliver on measures of performance in areas of responsibility
- Direct experience with FDA/EU regulatory authority
Desired Qualifications
- PhD in related field strongly preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.