Biostatistics Project Leader

Overview

• Lead statistical activities for vaccine projects in clinical development and post-marketing stages, ensuring scientific validity and external stakeholder relevance.
• Collaborate with cross-functional teams to develop and gain approval for clinical development plans and submissions.
• Contribute to groundbreaking vaccine research using advanced statistical methodologies and AI-driven innovations.
• Mentor team members, promoting teamwork, operational efficiency, and quality standards.
• Ensure compliance with SOPs and departmental standards throughout project execution.
• Communicate trial results internally and externally, supporting strategic decision-making and regulatory submissions.
• Shape the future of immunization by contributing to next-generation vaccine development.

Key Responsibilities & Duties

• Develop and oversee clinical development plans in collaboration with medical and global project teams.
• Ensure statistical aspects of clinical trials, including data capture, randomization, and analysis plans.
• Mentor team members, fostering innovation and adherence to quality standards.
• Communicate trial results and collaborate on their scientific interpretation and strategic impact.
• Contribute to external communications, including submissions for marketing authorization or label improvement.
• Promote teamwork and operational efficiency within project teams.
• Ensure compliance with SOPs and departmental standards in all statistical activities.

Job Requirements

• PhD/MS in Statistics, Biostatistics, or related field with 6+ years of pharmaceutical experience.
• Proven expertise in clinical development, post-marketing activities, and regulatory agency interactions.
• Broad knowledge of advanced statistical concepts and techniques.
• Strong study management, interpersonal, and communication skills.
• Experience in statistical aspects of clinical trials, including data capture and analysis plans.
• Ability to mentor team members and promote operational efficiency and innovation.
• Commitment to compliance with SOPs and departmental standards.