Job Title: Statistical Project Leader
Location: Cambridge, MA
Main Responsibilities:- Lead one moderate project, one or several indications, or a highly complex large study in late phase rare disease development; lead multiple projects including at least one complex project;
- With minimal direction from group head, direct statistical support and provide scientific leadership for responsible project. Accountable for statistical aspects of early or late clinical development/medical affairs plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity
- Mentor people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure project team compliance with SOPs and departmental standards.
- Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas. Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC). Capacity to respond to unscheduled increase in project workload.
- Provide technical guidance and mentoring to junior staff.
- Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
- Represents statistics in regulatory meetings
- Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross function initiatives; Contribute to operation process optimization and provide inputs to statistics standards.
About You:Basic Qualifications:
Education:
- PhD or Master's degree in Statistics, Biostatistics, Applied Mathematics, Bioinformatics, Computational Biology, Data Science, or related quantitative/scientific discipline
Experience:
- PhD holders, minimum 5 years of experience or Master holders, minimum 7 years of experience in pharmaceutical, biotech/biologics, medical device/diagnostics or related industries
- Academic or research experience may be considered
Preferred Qualifications:
- Demonstrated strong project/study management skills
- Broad knowledge and good understanding of advanced statistical concepts and techniques
- Broad knowledge of pharmaceutical clinical development
- Broad experience in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies or other external stakeholders
- Experience in the relevant therapeutic area
- Demonstrated strong interpersonal and communication skills
- Ability to represent Sanofi in cross-company activities such as consortiums or professional associations
Why Choose Us:
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Achieve genuine work-life balance in a supportive R&D environment.
The salary range for this position is:
$148,500.00 - $214,500.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
