Role Summary
Statistical Project Leader (Associate Director) within Sanofiβs Evidence Generation and Decision Science (EGDS) Biostatistics I&I team. 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. Location: Morristown, NJ and Cambridge, MA.
Responsibilities
- Proficient level of statistical and scientific contribution to clinical development plans, studies and submission activities (when applicable), with minimal guidance from senior statistical project leader or team leader
- Accountable for statistical aspects 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 compliance with Sanofi 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-company activities (e.g. working groups, consortiums or professional associations)
Qualifications
- Required: PhD or MS in statistics or related discipline with at least 5 years of pharmaceutical experience in clinical development, including experience with biotech, pharma, CROs, health authorities and academic clinical research centers
- Required: Broad knowledge and understanding of advanced statistical concepts and techniques; ability to perform advanced statistical analyses using SAS or R
- Required: Demonstrated strong project management, interpersonal and communication skills
- Required: Demonstrated ability to represent organizations in cross-company activities (e.g. consortiums or professional associations)
- Required: Proficient in written and spoken English
Skills
- Statistical concepts and techniques
- Advanced analyses using SAS or R
- Project management and leadership
- Cross-functional collaboration and communication
Education
- PhD or MS in statistics or related discipline