Statistical Programmer

Company: TCS

Role: Healthcare & Life Sciences Other
Industry: Pharmaceutical & Life SciencesDepartment: Healthcare & Life SciencesEmployment Type: Full-time, PermanentRole Category: Healthcare & Life Sciences OtherJob Location: Mumbai, Pune, Bangalore, Delhi-NCRExperience Range: 512 years

Position Overview

TCS is seeking experienced Statistical Programmers with expertise in CDISC standards to support programming activities across multiple therapeutic areas. The role involves overseeing statistical programming deliverables, ensuring compliance with quality processes, and managing project timelines.

Key Responsibilities

• Lead statistical programming activities for one or more compounds, indications, or therapeutic areas.
• Manage a team of statistical programmers, including project resource planning.
• Ensure high-quality deliverables, adherence to processes, and consistency across projects.
• Develop and oversee the creation of SAS programs for ADaM datasets as per CDISC standards.
• Support generation of Tables, Listings, and Figures (TLFs) for clinical studies.
• Maintain consistency of ADaM datasets for both standalone studies and integrated submissions.
• Prepare documentation for regulatory filings, including reviewer guides and data definition documents.
• Contribute to the development of standard SAS macros and SOPs.
• Mentor, guide, and prepare career development plans for assigned staff.
• Participate in recruitment, onboarding, and capability-building initiatives.

Required Skills & Competencies

• Proficiency in SDTM, ADaM, and TLF generation.
• Strong knowledge of CDISC standards.
• Hands-on expertise with SAS programming.
• Leadership and mentoring capabilities.
• Excellent attention to detail and ability to meet regulatory standards.

Education

• UG: B.Pharm (any specialization)
• PG: M.Pharm (any specialization)

Key Skills

• ADaM
• SDTM
• TLF
• CDISC Standards
• SAS Programming