Sanofi · 1 day ago
Programing Project Leader
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
4+ years expSanofi is a global healthcare company delivering innovative solutions to protect people from infectious diseases. The Programming Project Leader will oversee all programming activities for projects, ensuring high-quality deliverables and compliance with regulatory standards.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Provides and maintains project plan for all projects/studies including milestones, tasks, and coordination of programming activities
Provides leadership and guidance to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements
Ensures standardization and consistency of documents and programming deliverables across studies (clinical study reports, CSR) and for integrated analyses (ISS/ISE)
Provides technical guidance and leadership to metadata specifications and project/study specific data requirements
Plans and leads regulatory submission activities
Supervises the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities
Participates in clinical project meetings and provide input, whenever relevant
Identifies areas for improvements within a project and make suggestions for changes and implementation, as appropriate
Acts as mentor to junior staff with regard to programming techniques, project management and implementation of standards
Assists in the development, evaluation and support of junior staff and contractors
Provides technical expertise and hands-on support to the programming team
Leads/participates in working groups either within-department or as a department representative cross-function
Supports department initiatives and task forces and contributes to department standards and processes
Qualification
Required
Excellent technical skills in statistical programming, with advanced knowledge in SAS, R and other statistical computing software
Ability to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project, with minimal supervision
Knowledge on regulatory requirement evolution (SDTM, SDRG, ADRG, ADAM, XML format, etc…); thorough understanding of pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques and clinical trial principles) and ability to manage and lead regulatory submissions
Excellent understanding of internal SOPs and industry regulations
Ability to act as the key contact for programming management, to anticipate activities, alert for potential issues and propose adequate solutions
Ability to collaborate with external partners (CROs, Partners, etc.) and manage outsourced activities
Excellent verbal and written communication skills in an English global environment. Ability to have efficient exchanges with partners, service providers, and colleagues across geographical locations
Strong skills that demonstrate initiative, motivation, problem-solve and teamwork in global interdisciplinary teams
Ability and mindset to embrace change and continuously improve programming practice
Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred
Master degree and 4+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry
Bachelor degree and 6+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry
PhD candidates will be considered
Preferred
Experience with other operating systems and packages such as UNIX, MS Office
Experience with other Statistical and Graphics software packages such as R, SPLUS, JMP
Experience with an Electronic Data Capture (EDC), such as RAVE, Oracle Clinical
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-06
BioWorld Financial Watch
2026-01-06
2026-01-06
Company data provided by crunchbase