Senior Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic leadership for statistical initiatives that support late-stage vaccine development programs.

• Ensure statistical integrity throughout clinical development, translational sciences, and CMC.

• Offer strategic insights to senior leadership regarding the statistical ramifications of development strategies.

• Direct the statistical strategy for Phase 2/3 clinical trials.

• Supervise statistical outputs from CROs and external collaborators.

• Collaborate with clinical and translational teams to enhance immunobridging models.

• Direct the statistical design and analysis of critical nonclinical studies.

• Manage relationships with external vendors, key opinion leaders, and regulatory bodies.

• Mentor and cultivate the skills of internal statisticians and other team members.

⛳️ Requirements

• A minimum of a graduate degree in Biostatistics, Statistics, or a related discipline; a doctoral degree is highly preferred.

• Over 14 years of experience in biostatistics within the pharmaceutical or biotech sectors, with significant leadership in late-phase clinical development.

• Proficiency in clinical trial design, regulatory submissions, and statistical modeling specifically related to vaccines or infectious diseases.

• Experience with immunobridging, logistic regression methods, and both Bayesian and frequentist modeling techniques.

• Familiarity with CMC statistics, assay validation, and the design of nonclinical studies.

• Strong skills in statistical programming (e.g., SAS, R, Python); familiarity with CDISC standards is advantageous.

• Demonstrated leadership, effective communication, and the ability to collaborate across functions.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Flexible spending accounts.

• Flexible vacation and sick leave policies.

• Employer-paid life and disability insurance.

• 11 federal holidays.

• End-of-year winter break.

• Employer-matching 401(k) plan.