Statistical Project Leader

Role Summary

Statistical Project Leader (Associate Director) in Biostatistics Immunology & Inflammation. Location: Cambridge, MA; Morristown, NJ. You will provide statistical leadership and guidance as the lead statistician on one or more project teams, developing innovative statistical solutions to support critical trial decision-making and advance treatment across all phases of drug development. You will be supported by a Biostatistics group within Evidence Generation and Decision Science, with opportunities for career development and meaningful impact on patients.

Responsibilities

• Expert level of statistical and scientific contribution to clinical development plans, studies and submissions activities (when applicable), with minimal guidance from senior statistical project leader or team leader
• Accountable for statistical aspects of including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.
• Plan, monitor and manage project activities, timelines, processes, and resources to ensure operational excellence and align practices in compliant with SOPs and Biostatistics standards.
• Develop productive collaboration with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
• Mentor junior project team members and nurture a culture of productive teamwork, quality, operational efficiency, and innovation.
• Represent statistics in cross-functional and cross-organization activities (e.g. working groups, consortiums or professional associations).

Qualifications

• PhD/MS in statistics or related discipline with typically at least 6 years of pharmaceutical experience in clinical development, including experience with biotech, pharma, Clinical Research Organizations (CROs), health authorities and academic clinical research centers
• Broad knowledge and good understanding of advanced statistical concepts and techniques; ability to perform advanced statistical analyses using SAS or R
• Demonstrated 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

• Advanced statistical concepts and techniques
• Proficiency in SAS and/or R
• Project management
• Interpersonal and communication skills
• Cross-functional/cross-organizational collaboration
• Written and spoken English proficiency

Education

• PhD or MS in statistics or a related discipline