Senior Programming Project Lead

About the job

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 projec