Senior Statistical Project Leader (Director)
Sanofi
5 months ago
Remote friendly (Morristown, NJ)
United States
Clinical Research and Development
Main Responsibilities:
- Provide advanced statistical and scientific contributions to clinical development plans, studies, and submissions activities (when applicable); provide strategic statistical leadership for responsible projects.
- Plan, monitor, and manage project activities, timelines, processes, and resources to ensure operational excellence and align practices with Sanofi SOPs and Biostatistics standards.
- Develop productive collaboration with other functions in the project team, with other statistics project leaders, and communicate with senior leadership.
- Mentor junior project team members and foster a culture of teamwork, quality, operational efficiency, and innovation.
- Represent statistics in challenging regulatory meetings, key scientific/technology working groups, or cross-functional initiatives.
Qualifications:
- PhD/MS in Statistics (or related discipline) with at least 8 years of pharmaceutical experience in clinical development, including experience with Biotech, Pharma, CROs, health authorities, and academic clinical research centers.
- Strong understanding of clinical development and advanced statistical concepts and techniques; Oncology experience is a plus.
- Proven experience in clinical development or post-marketing activities (e.g., submissions and interactions with regulatory agencies or external stakeholders).
- Demonstrated leadership plus excellent interpersonal/communication and project management skills.
- Experience representing organizations in cross-company activities (e.g., consortiums or professional associations).
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Provide advanced statistical and scientific contributions to clinical development plans, studies, and submissions activities (when applicable); provide strategic statistical leadership for responsible projects.
- Plan, monitor, and manage project activities, timelines, processes, and resources to ensure operational excellence and align practices with Sanofi SOPs and Biostatistics standards.
- Develop productive collaboration with other functions in the project team, with other statistics project leaders, and communicate with senior leadership.
- Mentor junior project team members and foster a culture of teamwork, quality, operational efficiency, and innovation.
- Represent statistics in challenging regulatory meetings, key scientific/technology working groups, or cross-functional initiatives.
Qualifications:
- PhD/MS in Statistics (or related discipline) with at least 8 years of pharmaceutical experience in clinical development, including experience with Biotech, Pharma, CROs, health authorities, and academic clinical research centers.
- Strong understanding of clinical development and advanced statistical concepts and techniques; Oncology experience is a plus.
- Proven experience in clinical development or post-marketing activities (e.g., submissions and interactions with regulatory agencies or external stakeholders).
- Demonstrated leadership plus excellent interpersonal/communication and project management skills.
- Experience representing organizations in cross-company activities (e.g., consortiums or professional associations).
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.