About the job

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) covering all of Sanofi's therapeutic areas (excluding oncology). Act as statistical consultant within company.   

Major Duties and Responsibilities

Be a key driver of international project teams to contribute to the early development (in terms of decision-making strategy, project management, submission dossier). 

With minimal direction from group head, direct statistical support and provide scientific leadership for responsible projects.  Accountable for statistical aspects of early development in the clinical development plans, studies and related submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity

Provide/develop statistical expertise within the team, department or cross-functions e.g.,  pharmacology, pharmacokinetics, precision medicine or biomarker teams).

Develop productive collaboration with other functions in the aligned study/project teams, with other statistics project leaders and in communicating with senior leadership.

Stay informed with data being generated in the current clinical development programs and by competitors.

Proactively make proposals to improve study designs, analyses and, more broadly, the efficiency and effectiveness of the department through continuous bibliographic monitoring.

Be accountable of high-quality contribution from study protocol to the clinical report.

Promote teamwork, innovation, quality, and operational efficiency. Ensure study/project teams compliance with SOPs and departmental standards.

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.

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

PhD/MS in statistics or related discipline with at least 6 years of pharmaceutical experience

Demonstrated strong  project/study management, interpersonal and communication skill; strong capacity for anticipation, organization and coordination; leadership, including supervision of contractors; ability to work as a team player and interact with all stakeholders.

Broad knowledge and good understanding of advanced statistical concepts and techniques, including Bayesian techniques. Ability to propose and promote innovation in clinical development plans and analyses.

Broad knowledge of pharmaceutical clinical development

Experience in the relevant therapeutic area desired

Autonomous in the management of activities; organized, able to efficiently manage multiple and variable deadlines. 

Ability to be flexible and adapt quickly to the changing needs of organization.

Ability to represent Sanofi in cross-company activities such a consortiums or professional associations

Experience in interactions with regulatory agencies or other external stakeholders

Oral and written fluently in English

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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