Project Programming Lead
Sanofi
August 29, 2026
Remote friendly (Morristown, NJ)
United States
$122,250 - $176,583.33 USD yearly
Clinical Research and Development
Responsibilities:
- Lead scientific programming for a large or multiple small vaccines projects across late-phase and early/post-marketing clinical development.
- Own all scientific programming activities for the assigned project(s); provide technical/operational leadership and hands-on support.
- Manage programming project planning, timelines, and global resource utilization.
- Ensure standardization/consistency of specifications and programming deliverables across studies and integrated analyses.
- Drive regulatory submissions, including electronic submission packages; ensure CDISC data packages meet Health Authority expectations (e.g., FDA, PMDA, CDE, KFDA).
- Oversee outsourcing engagements; coordinate CRO partnership and ensure operational quality and timely delivery via KPI follow-up and lessons learned.
- Collaborate cross-functionally with project statistician(s) and contribute inputs in clinical project meetings.
- Mentor junior staff on programming techniques and standards.
Qualifications:
- Bachelor’s degree in Statistics, Mathematics, Computer Science, or related health sciences.
- 7+ years hands-on SAS or R programming experience.
- Proficiency in CDISC standards (SDTM/ADaM) and regulatory submission requirements.
Preferred:
- Experience overseeing study/project-level programming deliverables in global settings; experience with third-party vendors.
- Demonstrated leadership in multicultural teamwork; ability to embrace/lead change and improve team practices.
- Experience implementing automation and digital transformation.
- Fluent in English (additional languages a plus).
Benefits (as stated):
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Lead scientific programming for a large or multiple small vaccines projects across late-phase and early/post-marketing clinical development.
- Own all scientific programming activities for the assigned project(s); provide technical/operational leadership and hands-on support.
- Manage programming project planning, timelines, and global resource utilization.
- Ensure standardization/consistency of specifications and programming deliverables across studies and integrated analyses.
- Drive regulatory submissions, including electronic submission packages; ensure CDISC data packages meet Health Authority expectations (e.g., FDA, PMDA, CDE, KFDA).
- Oversee outsourcing engagements; coordinate CRO partnership and ensure operational quality and timely delivery via KPI follow-up and lessons learned.
- Collaborate cross-functionally with project statistician(s) and contribute inputs in clinical project meetings.
- Mentor junior staff on programming techniques and standards.
Qualifications:
- Bachelor’s degree in Statistics, Mathematics, Computer Science, or related health sciences.
- 7+ years hands-on SAS or R programming experience.
- Proficiency in CDISC standards (SDTM/ADaM) and regulatory submission requirements.
Preferred:
- Experience overseeing study/project-level programming deliverables in global settings; experience with third-party vendors.
- Demonstrated leadership in multicultural teamwork; ability to embrace/lead change and improve team practices.
- Experience implementing automation and digital transformation.
- Fluent in English (additional languages a plus).
Benefits (as stated):
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.