Project Programming Lead
Sanofi
August 29, 2026
Remote friendly (Waltham, MA)
United States
$122,250 - $176,583.33 USD yearly
Clinical Research and Development
Main Responsibilities:
- Lead scientific programming deliverables: provide leadership, guidance, and hands-on support to ensure high-quality, timely outputs in 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 studies and integrated analyses.
- Drive regulatory submissions: lead electronic submission packages and ensure CDISC data packages comply with Health Authority expectations (e.g., FDA, PMDA, CDE, KFDA).
- Oversee outsourcing engagements: guide team interactions with external resources.
- Collaborate cross-functionally: partner with project statisticians; participate in clinical project meetings and provide relevant inputs.
- Transversal responsibility/process improvement: contribute to process improvements and support outsourcing operation management (CRO partnership coordination, KPI follow-up, lessons-learned meetings, partnership governance/process documentation, and shared IT environments).
- Mentor junior staff on programming techniques and standards implementation.
Basic Qualifications:
- Bachelor’s degree in Statistics, Mathematics, Computer Science, or related health sciences.
- 7+ years hands-on experience with SAS or R programming; proficiency in CDISC standards (SDTM/ADaM) and regulatory submission requirements.
Preferred Qualifications:
- Experience coordinating end-to-end programming deliverables (preparation/execution/reporting/documentation) in global settings; experience working with third-party vendors.
- Demonstrated leadership and multicultural teamwork; ability to lead change and improve team practices.
- Experience implementing automation and digital transformation initiatives.
- Fluent in English (additional languages a plus).
Benefits:
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Lead scientific programming deliverables: provide leadership, guidance, and hands-on support to ensure high-quality, timely outputs in 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 studies and integrated analyses.
- Drive regulatory submissions: lead electronic submission packages and ensure CDISC data packages comply with Health Authority expectations (e.g., FDA, PMDA, CDE, KFDA).
- Oversee outsourcing engagements: guide team interactions with external resources.
- Collaborate cross-functionally: partner with project statisticians; participate in clinical project meetings and provide relevant inputs.
- Transversal responsibility/process improvement: contribute to process improvements and support outsourcing operation management (CRO partnership coordination, KPI follow-up, lessons-learned meetings, partnership governance/process documentation, and shared IT environments).
- Mentor junior staff on programming techniques and standards implementation.
Basic Qualifications:
- Bachelor’s degree in Statistics, Mathematics, Computer Science, or related health sciences.
- 7+ years hands-on experience with SAS or R programming; proficiency in CDISC standards (SDTM/ADaM) and regulatory submission requirements.
Preferred Qualifications:
- Experience coordinating end-to-end programming deliverables (preparation/execution/reporting/documentation) in global settings; experience working with third-party vendors.
- Demonstrated leadership and multicultural teamwork; ability to lead change and improve team practices.
- Experience implementing automation and digital transformation initiatives.
- Fluent in English (additional languages a plus).
Benefits:
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.