Vaccines clinical research design and endpoints knowledge
This role provides technical and operational leadership for scientific programming activities across the entire Vaccines R&D value chain from pre-clinical to post-marketing support
Job Summary
This role provides technical and operational leadership for scientific programming activities across the entire Vaccines R&D value chain from pre-clinical to post-marketing support.
The successful candidate will ensure compliance with Health Authorities' expectations including FDA, PMDA, CDE, and KFDA while leading regulatory submission activities.
As a leader within the Hyderabad Hub, you will guide junior staff, optimize resource allocation, and drive standardization across integrated analyses.
Matching Summary
This role provides technical and operational leadership for scientific programming activities across the entire Vaccines R&D value chain from pre-clinical to post-marketing support.
Skills & Requirements
Must-have
10+ years statistical programming experience
Advanced SAS BASE STAT MACRO GRAPH SQL R skills
Vaccines clinical research design and endpoints knowledge
CDISC package delivery and regulatory submission expertise
Leadership of scientific programming project teams
Nice-to-have
Experience with outsourcing engagement oversight
Ability to lead cross-functional working groups
Strong interpersonal skills for global teamwork
Innovation mindset in programming practices
Key Requirements
Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or related health sciences
10+ years experience in statistical programming within clinical research
Proven track record in preparing and executing study-level programming deliverables