Statistical Programmer

Role-1:

Location:

Experience:

Statistical Programmer

Key Responsibilities:

• Develop and validate SDTM datasets in compliance with CDISC standards
• Interpret mapping specifications and raw data
• Prepare the

  Study Data Reviewer's Guide (SDRG)

• Collaborate with global clinical teams and statisticians
• Maintain documentation and ensure submission compliance

Requirements:

• 4+ years of hands-on SDTM programming experience
• Proficient in SAS and CDISC implementation
• Strong knowledge of clinical trial data and regulatory standards
• Excellent attention to detail and communication skills

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Role-2:

Location:

Employment Type:

Experience:

Notice Period:

Senior Statistical Programmer

Key Responsibilities:

• Design and develop SDTM and ADaM datasets per CDISC
• Program and validate Tables, Listings, and Figures (TLFs)
• Perform quality control and regulatory submission support
• Work closely with Biostatistics and Clinical Data teams
• Drive programming timelines and deliverables across studies

Requirements:

• 8+ years of SAS programming in a clinical research environment
• Expert in SDTM, ADaM, and TLF generation
• Strong understanding of FDA/EMA submission standards
• Good communication, documentation, and collaboration skills