Job Title: Statistical Project Leader  

Location: Morristown, NJ

Provide leadership and guidance as the lead statistician on one or more project team(s), accountable for all methodological and statistical aspects of project(s).  Act as statistical consultant within company.    

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;  

• 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

North America Applicants Only

The salary range for this position is:

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.