Statistical Project Leader

Main Responsibilities

Lead one moderate project, one or several indications, or a highly complex large study (eg. CVOT) in late phase or Onco early development; lead multiple projects including at least one complex project, in non-Onco early development and MA;

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.

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

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