Lead Biostatistician (IVD Clinical)

Accountabilities

• Provide statistical leadership across clinical development activities, supporting study design, execution, analysis, and regulatory documentation.
• Partner with cross-functional teams to translate complex data into meaningful insights while ensuring compliance with clinical research standards.
• Design, review, and provide statistical input for clinical study protocols and statistical analysis plans.
• Led the execution of statistical analyses according to predefined plans, protocols, and regulatory requirements, including exploratory and ad-hoc analyses.
• Develop high-quality statistical documentation, presentations, and reports detailing methodologies, results, and interpretations.
• Communicate complex statistical concepts and findings clearly to technical and non-technical stakeholders.
• Identify statistical risks, raise critical issues, and recommend solutions within cross-functional project teams.
• Support regulatory submission activities by ensuring robust statistical methodologies and analysis approaches.
• Mentor and provide technical guidance to junior team members, helping strengthen statistical capabilities across the organization.
• Contribute to continuous improvement initiatives and perform additional responsibilities as needed.

Requirements

• An experienced biostatistics professional with strong expertise in clinical research, regulated environments, and statistical methodology.
• Master’s degree in Biostatistics, Statistics, or a related quantitative field with 5+ years of relevant experience, or PhD with 3+ years of relevant experience.
• Strong experience using statistical analysis software such as R, SAS, or JMP, with preference for R expertise.
• Previous experience in diagnostics, molecular testing, oncology, or related healthcare fields is preferred.
• Expert understanding of probability theory, statistical methods, and their practical application in clinical research.
• Familiarity with clinical trial design principles, industry best practices, and regulatory standards.
• Prior experience interacting with regulatory organizations such as the FDA is preferred.
• Strong written and verbal communication skills, with the ability to explain complex statistical concepts to varied audiences.
• Demonstrated ability to collaborate effectively across multidisciplinary teams and produce high-quality documentation.

Benefits

• Competitive compensation package with a salary range of $144,000 - $180,000 USD.
• Annual performance incentive bonus opportunities.
• Long-term equity awards.
• Comprehensive medical, dental, and vision coverage.
• 401(k) plan with company matching contributions.
• Generous paid time off and company holidays.
• Wellness programs and additional work-life support benefits.
• Opportunities to work on innovative healthcare technologies with meaningful patient impact.
• Collaborative environment with opportunities for professional growth and development.