Senior Director of Biostatistics

Job Summary

Providing leadership for clinical development programs, the full-time Senior Director of Biostatistics will manage statistical activities for clinical trials, including trial design, statistical analysis plans, and data interpretation, while collaborating with cross-functional teams in a remote working environment.

Key Responsibilities

• Lead the biometrics team, providing statistical input for study design, protocol development, and regulatory interactions
• Promote innovative statistical methods and collaborate with internal teams to ensure high-quality data and timely project deliverables
• Oversee CRO/vendor interactions, ensuring accurate and timely delivery of statistical analyses and related documents for global health authorities

Required Qualifications

• PhD in Biostatistics, Statistics, or a related field with 10-12 years of experience in biostatistics within the pharmaceutical or biotech industry
• Strong knowledge of statistical methodologies and experience with regulatory submissions
• Proficiency in statistical software (e.g., SAS, R) and familiarity with CDSIC standards
• Successful track record of working independently in a matrixed organization
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a multidisciplinary team environment