Project Lead

Sanofi

Lead scientific programming for vaccine clinical development projects at Sanofi. Ensure high-quality programming deliverables and compliance with standards and regulatory requirements.

Posted 8/1/2026full-timeMorristown • Massachusetts, New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $122,250 - $176,583 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in SAS or R programming, with a strong focus on CDISC standards and regulatory submissions. Proven ability to lead programming deliverables, manage resources, and mentor junior staff while ensuring compliance and process improvement.

Highest-signal resume keywords

SAS ProgrammingR ProgrammingCDISC StandardsRegulatory SubmissionsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisData ManagementProgramming TechniquesAutomation ImplementationDigital Transformation

Soft Skills

LeadershipCollaborationMentoringCommunication

Industry Keywords

Health Authority ComplianceFDAPMDACDEKFDAOutsourcing ManagementGlobal Project Coordination

About the role

Key responsibilities & impact

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
Mentor - Provide guidance to junior staff on programming techniques and standards implementation

Requirements

What you’ll need

Bachelor's degree in Statistics, Mathematics, Computer Science or related health sciences field
7+ years of hands-on experience in SAS or R programming
proficiency in CDISC standards (SDTM/ADaM) and regulatory submission requirements
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 experience implementing automation and digital transformation initiatives
Fluent in English; additional languages a plus.

Benefits

Comp & perks

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave