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