Project Programming Lead
About The Position
As Project Programming Lead within our Vaccines Biostatistical Sciences team, you'll lead the scientific programming of a large or couple of small project(s) from our vaccines portfolio, bringing data to life along the development value chain. Assume responsibility for all scientific programming activities related to a late phase clinical development project or multiple projects in early or post-marketing phase. The incumbent provides technical and operational leadership, accountable for all programming activities for the related project(s). In addition, assume transversal responsibility like outsourcing operation management. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
Requirements
- Masters degree in Statistics, Mathematics, Computer Science or related health sciences field.
- 7+ years of hands-on experience in SAS and R programming, proficiency in CDISC standards (SDTM/ADaM), and regulatory submission requirements.
Nice To Haves
- Proven success performing, coordinating and overseeing the preparation, execution, reporting and documentation of all study and project-level asset development programming deliverables in a global setting.
- Proven experience in dealing with third party vendors.
- Demonstrated leadership that includes interpersonal skills necessary for effective teamwork in multi-cultural setting, ability to embrace and lead change, being curious to innovate and to bring improvement in the team practices where it adds value.
- Demonstrated experience implementing automation and digital transformation initiatives.
- Fluent in English; additional languages a plus.
Responsibilities
- Lead scientific programming deliverables - Provide leadership, guidance and hands-on support to ensure high-quality, timely programming outputs while ensuring compliance with internal standards, SOPs and regulatory requirements.
- Manage project planning & resources - Plan and track programming activities, timelines, and resource utilization in a global setting.
- Ensure standardization & consistency - Maintain consistency in specifications and programming deliverables across individual studies and integrated analyses.
- Drive regulatory submissions - Lead regulatory submission activities, including electronic submission packages, ensuring CDISC data packages comply with Health Authority expectations (FDA, PMDA, CDE, KFDA, etc.).
- Oversight activities for outsourcing engagements and guide team interactions with external resources.
- Collaborate cross-functionally - Partner effectively with project statistician(s); participate in clinical project meetings and contribute relevant inputs.
- Act into transversal responsibility, contributing to process improvement or ensuring outsourcing operation management (coordinate the CRO partnership from a business perspective; Ensure the operational quality and timely delivery through the follow-up of Key Performance Indicators (KPIs) and the organization of lessons learned meetings; Contribute to the maintenance of partnership governance and process documentation and any shared IT environments, such as Teams or SharePoint sites).
- Mentor - Provide guidance to junior staff on programming techniques and standards implementation.
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Senior
