We are a worldwide leader in human Vaccines for 100 years. We develop and produce a broad range of high-quality vaccines to protect people around the world from severe diseases at each and every stage of life. We have continued strong growth and best in class products to protect against many diseases such as flu, meningitis, polio, pertussis, bronchiolitis and much more. We improve people’s lives by developing innovative vaccination solutions against many diseases.

We innovate in vaccines manufacturing through digitalization and we engage in partnerships for disease prevention, to sustainably maximize vaccination impact.

We give employees the opportunity to grow and encourage them to build diversified career paths within the Sanofi organization.

Our Team:

The Sanofi Vaccines Scientific Programming team is part of our Global Biostatistical Sciences department, where we partner with biostatisticians to manage the analysis and submission of our Vaccine trials. The Scientific Programming team primarily focuses on clinical trials, with some support to pre-clinical and non-clinical trials. SAS remains our statistical computing software for submission-related analyses, but we actively use additional tools such as R, Tableau, and Power BI and are always open to new ways of working that will bring simplicity and allow us to focus our expertise where it is most valuable. We are a global team with colleagues and partners currently clustered largely in the USA, France, China, India, and Australia.  

Main responsibilities:

The Senior Programming Project Leader is a scientific programming leader for one or more large, high complexity vaccine projects in clinical development and/or post-marketing stage. They provide technical and operational leadership for their scientific programming project team(s) and are accountable for all programming activities from study start to regulatory submission and post marketing support at the project level. The Senior Programming Project Leader is accountable for the integrity of the clinical data prepared for submission across all studies contributing to a project, ensuring it meets regulatory requirements for acceptance of the project’s electronic submission and adheres correctly to CDISC data standards.

The Senior Programming Project Leader operates in a worldwide context with colleagues located in different countries and with different cultures. They have no direct reports but indirect ones delivering more on the operational side, requiring the incumbent to demonstrate leadership in engaging and communicating. They interact with other teams within the department, Clinical, Regulatory, Global Program Head, Immunology, Medical Writing, Data Management, etc. to coordinate and negotiate inter-dependent milestones. They also have interactions with senior R&D Leaders to communicate complex programming concepts that affect regulatory submissions.

The primary responsibilities of the Senior Programming Project Leader include the following.

1. Apply advanced technical experience as a Scientific Programming leader at vaccine project level:

• Provide project leadership, management, and technica; guidance to ensure high quality and timely scientific programming deliverables within a project. Ensures technical validity, supervises quality control (QC) methods, and ensures compliance to internal standards/standard operating procedures (SOPs) and regulatory requirements. May participate hands-on with most complex/high-priority deliverables.

• Ensure standardization and consistency in specifications and programming deliverables across individual studies and for integrated analyses.

• Take accountability for and provides technical guidance for metadata specifications and project-/study-specific data requirements.

• Lead complex regulatory submission activities, including electronic submission packages; represent Programming in submission task forces and meetings with health authorities.

• Accountable for ensuring the clinical data CDISC packages are delivered and comply with Health Authorities’ (eg: FDA, PMDA, CDE, KFDA,..) expectations.

2. Act in a project management capacity to ensure scientific programming activities are conducted and completed within the set scope, schedule, and budget:

• Plan and track programming project activities, timelines, and resource use in cross-site global setting; provide justification for planned resource needs, seek to optimize resource utilization through efficient and well-managed resource allocation and across projects or areas, respond to unscheduled changes in project workload with solutions.

• Collaborate effectively with project statistician and with other functions in the aligned project team; participate in clinical project meetings and provide inputs, whenever relevant.

3. Act as Scientific Programming Leader both within Global Biostatistical Sciences department and cross-functionally:

• Oversee project activities across geographical locations; support group head to define team members’ priorities, performance review and development areas; promote teamwork, quality, operational efficiency, and innovation.

• Act as a key contact for programming management; identify opportunities for improvement and propose solutions.

• Lead departmental working groups on process, standards, and programming technical topics.

• Represent Programming in cross-functional working groups. Contribute to operational process optimization and provide inputs to programming standards.

• Represent Sanofi Vaccines in cross-company activities such as industry working groups or professional associations.

• Provide guidance to junior staff on programming techniques, project management, and implementation of standards; contribute to the programming recruitment process.

• Manage oversight activities for outsourcing engagements, with contribution to vendor selection, contract specifications, operation manuals, and service quality evaluation; guide team members to effectively interact with external resources.

About you

You are an influential leader with strong organizational and project management skills, a thorough understanding of the statistical programming activities and deliverables provided for vaccines regulatory submissions, and an expert in vaccines-specific CDISC data standards.

• Experience:

  • Clinical scientific / statistical programming experience in pharmaceutical industry, including significant vaccines therapeutic area experience.

  • Proven success performing, coordinating and overseeing the preparation, execution, reporting, and documentation of large or complex project-level programming deliverables and the contributing study-level activities.

• Soft skills:

  • Demonstrated leadership mindset that includes embracing change, innovating, continuously improving programming practices, motivation, and teamwork in a global team.

  • Demonstrated experience representing scientific programming effectively through internal and external audits, regulatory interactions, submissions and marketing authorizations.

  • Experience in the development, evaluation, and support of junior staff and flexible resources.

• Technical skills:

  • Advanced knowledge of SAS programming relevant to clinical data analysis.

  • Expertise in vaccines clinical development and regulatory submission process.

  • Expertise in vaccines-specific CDISC data standards.

• Education:

  • B.S. or M.S. in Biostatistics, Computer Science, Mathematics, Engineering, Life Sciences, or related discipline.

• Languages:

  • Effective oral and written communication skills in an English global environment and ability to have efficient exchanges with partners, service providers, and colleagues across geographic locations.

Pursue progress, discover extraordinary

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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Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected