Statistical Programmer

TCS is hiring for Statistical Programmer role

Job Location Mumbai - Pune | Bangalore | Hyderabad | Chennai | Indore | Kolkata | Noida

Educational Qualification(s) Required -Bachelors or masters 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
• Strong exposure across Phase IIV 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, Reviewers Guides
• FDA / PMDA / EMA regulatory submissions
• Onshoreoffshore 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

Thanks & Regards

Babeeta Shahi