Principal Biostatistician

Overview

• Lead statistical operations for clinical trial programs and projects remotely.
• Provide technical and operational leadership to interdisciplinary teams.
• Ensure sound statistical methodologies in study design and analysis.
• Mentor and develop less experienced biostatisticians and programmers.
• Contribute to drug development and commercialization strategies.
• Collaborate with regulatory agencies for compliance and documentation.
• Participate in organizational development and recruitment processes.
• Maintain expertise in statistical methodologies and regulatory requirements.

Key Responsibilities & Duties

• Manage clinical trial programs and provide statistical oversight.
• Write and review statistical analysis plans and reports.
• Validate statistical deliverables and ensure quality control.
• Provide statistical consultation for trial publications and presentations.
• Support sponsor interactions with regulatory agencies.
• Perform resource management and capacity analysis.
• Contribute to continuous improvement of governing documents.
• Participate in protocol design and development processes.

Job Requirements

• Ph.D. in statistical science or related field with 7+ years of experience.
• Master’s degree in statistics with 10+ years of relevant experience.
• Proven ability in statistical methodologies and regulatory compliance.
• Expertise in clinical trial design and statistical analysis.
• Experience mentoring and developing statistical teams.
• Strong communication and collaboration skills.
• Proficiency in statistical programming and data management.
• Ability to work effectively in a remote environment.