Job Location Mumbai -
Pune | Bangalore | Hyderabad | Chennai | Indore | Kolkata | Noida
Educational Qualification(s) Required -
Bachelor’s or master’s degree in Statistics, Mathematics, Pharmacy, Biotechnology, or Computer Science
Experience
Senior Statistical Programmer: 5+ years of hands-on statistical programming experience
Lead Statistical Programmer: 8+ years of hands-on statistical programming experience
Robust exposure across Phase I–IV clinical trials
Therapeutic expertise in Oncology, Immunology, and Neuroscience
Technical Expertise
SAS Programming (Base SAS, Macros, SQL)
SDTM, ADaM & TLFs
CDISC Standards
Dataset and TLF development, validation, and maintenance
Pinnacle21, Define.xml, Reviewer’s Guides
FDA / PMDA / EMA regulatory submissions
Onshore–offshore collaboration and client communication
Roles & Responsibilities
Leads the statistical programming activities for a compound/indication.
Leads a team of statistical programmers and manages the resource planning for assigned staff.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
Ensures consistency of ADaM data sets for individual studies and integrated data