Project Programming Lead SAS R CDISC
Overview
You will own scientific programming deliverables for a large vaccine project or multiple small projects, ensuring high-quality outputs across the development value chain. You will lead a team of programmers and manage outsourcing operations, collaborating with project statisticians and regulatory experts. This role drives innovation through automation and digital transformation, shaping the future of vaccine development at Sanofi.
What You'll Do9
- 1Lead scientific programming deliverables, providing guidance and hands-on support to ensure high-quality, timely outputs while ensuring compliance with internal standards, SOPs, and regulatory requirements.
- 2Manage project planning and resources, tracking programming activities, timelines, and resource utilization in a global setting.
- 3Ensure standardization and consistency in specifications and programming deliverables across individual studies and integrated analyses.
- 4Drive regulatory submissions, including electronic submission packages, ensuring CDISC data packages comply with Health Authority expectations (FDA, PMDA, CDE, KFDA).
- 5Oversee outsourcing engagements and guide team interactions with external resources, coordinating the CRO partnership from a business perspective.
- 6Ensure operational quality and timely delivery through follow-up of Key Performance Indicators (KPIs) and organization of lessons learned meetings.
- 7Maintain partnership governance and process documentation, and shared IT environments such as Teams or SharePoint sites.
- 8Collaborate cross-functionally with project statisticians, participating in clinical project meetings and contributing relevant inputs.
- 9Mentor junior staff on programming techniques and standards implementation.
Requirements8
- 1Bachelor's degree in Statistics, Mathematics, Computer Science, or related health sciences field.
- 27+ years of hands-on experience in SAS or R programming.
- 3Proficiency in CDISC standards (SDTM/ADaM) and regulatory submission requirements.
- 4Proven success performing, coordinating, and overseeing preparation, execution, reporting, and documentation of all study and project-level asset development programming deliverables in a global setting.
- 5Proven experience dealing with third-party vendors.
- 6Demonstrated leadership with interpersonal skills for effective teamwork in a multicultural setting, ability to embrace and lead change, and curiosity to innovate and improve team practices.
- 7Demonstrated experience implementing automation and digital transformation initiatives.
- 8Fluent in English; additional languages a plus.
Salary Insight
$122 - $177k per year
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