Programming Project Lead – Vaccines | Hyderabad, India | Full-Time
Location: Hyderabad, Telangana, India
Experience Required: 10+ years in statistical programming and clinical research
Industry: Pharmaceuticals / Vaccines / Biostatistics & Clinical Programming
Employment Type: Full-Time
About Sanofi
Sanofi is a global biopharmaceutical leader committed to advancing health and protecting communities worldwide. Delivering over 500 million vaccine doses annually, our teams leverage cutting-edge immunoscience, data-driven insights, and AI-powered discovery to develop innovative solutions in vaccines, oncology, rare diseases, and neurology. At Sanofi, curiosity, collaboration, and scientific excellence drive real-world impact for millions of patients globally.
Our Hyderabad Hub plays a pivotal role in scientific programming and biostatistical sciences, supporting the full Vaccines R&D value chain—from preclinical research and clinical trials to translational studies and regulatory submissions.
Role Overview
The Programming Project Lead – Vaccines will provide technical and operational leadership for one or more scientific programming projects. You will oversee all programming activities across study start, regulatory submission, and post-marketing support. This role requires a combination of advanced technical expertise, project management skills, and team leadership to ensure high-quality, compliant, and timely deliverables.
Key Responsibilities
Scientific Programming Leadership:
Lead, mentor, and provide hands-on support to programming teams, ensuring accuracy, quality, and compliance with internal SOPs and global regulatory requirements.
Ensure standardization and consistency in specifications and programming outputs across studies and integrated analyses.
Provide technical guidance for metadata specifications and project-/study-specific data requirements.
Lead regulatory submission activities, including creation and validation of electronic submission packages.
Ensure delivery of CDISC-compliant clinical data packages aligned with global health authority expectations (FDA, PMDA, CDE, KFDA, etc.).
Project Management:
Plan, track, and manage project timelines, resources, and budgets in a global cross-site setting.
Collaborate effectively with project statisticians and cross-functional teams to support project goals.
Oversee outsourcing engagements, ensuring alignment with Sanofi standards and quality expectations.
Team and Operational Leadership:
Provide guidance to junior staff on programming techniques, project management, and regulatory compliance.
Contribute to process optimization, programming standards, and departmental initiatives.
Represent scientific programming in internal and external audits, regulatory interactions, and submissions.
Required Experience & Skills
Experience: 10+ years in clinical statistical programming, with vaccines experience preferred (designs, endpoints, statistical methods).
Technical Skills: Advanced proficiency in SAS (BASE, STAT, MACRO, GRAPH, SQL), R programming, and data management; knowledge of clinical trial processes, descriptive statistics, and CDISC standards.
Leadership: Proven ability to coordinate and oversee study- and project-level programming deliverables; demonstrated success in mentoring global teams.
Project Management: Ability to plan, prioritize, and manage complex programming projects with strong organizational skills.
Soft Skills: Excellent interpersonal, critical thinking, and communication skills; ability to work collaboratively and influence cross-functional teams.
Educational Requirements
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or Health Sciences, or equivalent experience in clinical programming and data management.
Fluency in English with highly effective written and oral communication skills.
Why Join Sanofi
Lead innovative vaccine programming projects that impact millions globally.
Work at the intersection of immunoscience, biostatistics, and AI-driven discovery.
Global exposure with opportunities for career growth and leadership development.
Inclusive and collaborative work culture that values curiosity, innovation, and excellence.
Competitive salary and benefits package aligned with global industry standards.
Sanofi is an equal opportunity employer, committed to diversity, equity, and inclusion. All qualified applicants will receive consideration regardless of race, color, ancestry, religion, sex, sexual orientation, gender identity, age, disability, or other legally protected characteristics.
Apply now to join Sanofi’s Hyderabad Hub and lead breakthrough vaccine programming projects that improve patient lives worldwide.
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