Statistical Project Leader

Role Summary

Statistical Project Leader responsible for providing statistical leadership on project teams, developing innovative statistical solutions to support trial decision-making, and driving activities across all phases of drug development within Biostatistics Immunology & Inflammation.

Responsibilities

• Expert level statistical and scientific contribution to clinical development plans, studies and submissions activities with minimal guidance.
• Accountable for statistical aspects including quality, external stakeholder relevance, and scientific validity.
• Plan, monitor and manage project activities, timelines, processes, and resources to ensure operational excellence and compliance with SOPs and Biostatistics standards.
• Develop productive collaboration with other functions and communicate with senior leadership.
• Mentor junior project team members and foster a culture of teamwork, quality, efficiency, and innovation.
• Represent statistics in cross-functional and cross-company activities (e.g., working groups, consortiums or professional associations).

Qualifications

• PhD or MS in statistics or related discipline with typically at least 6 years of pharmaceutical experience in clinical development, including exposure to biotech, pharma, CROs, health authorities, and academic clinical research centers.
• Broad knowledge of advanced statistical concepts and techniques; ability to perform advanced analyses using SAS or R.
• Strong project management, interpersonal and communication skills.
• Experience representing organizations in cross-company activities (e.g., consortiums or professional associations).
• Proficient in written and spoken English.

Skills

• Statistical leadership in clinical development
• Advanced statistical methods and software (SAS, R)
• Project management and cross-functional collaboration
• Communication with stakeholders and leadership

Education

• PhD or MS in statistics or related discipline

Additional Requirements

• Location: Cambridge, MA and Morristown, NJ