Director, Biostatistics Project Lead

About the job

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

Main responsibilities

• Lead large business critical vaccine project (one or several indications) in either clinical development or post-marketing stage.
• With minimal Biostat Franchise Lead oversight, take accountability in directing the biostatistical contribution and in providing scientific leadership for related project. The accountability covers statistical aspects of clinical development/medical affairs plans, studies and submissions activities, including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.
• Mentor and lead global Biostatistical and Scientific Programming team members involved and located in France/US/China or India. Promote global teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure project team compliance with SOPs and departmental standards.
• Plan and track Global Biostatistical Sciences activities, timelines and resource use globally. Provide justification for planned resource needs. Seek to optimize resource utilization through efficient and well-managed resource allocation. Capacity to respond to unscheduled increase in project workload.
• Ensure productive collaborations with other functions within the project team and in communicating with senior leadership.
• Represent biostatistics in cross function working groups within or outside Sanofi. Contribute to operation process optimization and provide inputs to statistics standards.

Required Education/Experience

• PhD/MS in statistics or related discipline with at least 8 years of pharmaceutical experience.
• Demonstrated strong project management, interpersonal and communication skills.
• Broad knowledge and good understanding of advanced statistical concepts and techniques.
• Proven 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 desired.
• Ability to represent Sanofi in cross-company activities such as consortiums or professional associations.