Statistical Programmer

Hiring: Statistical Programmer Clinical Data (SAS)

Locations: Mumbai | Pune | Bangalore | Hyderabad | Delhi

Industry: Pharma / Biotech / Clinical Research

Experience: 312 Years

About the Role

Latinum HR is hiring a Statistical Programmer Clinical Data for a leading Pharma/Biotech organization. This role plays a key part in supporting clinical trials, regulatory submissions, and integrated analyses while ensuring high-quality statistical programming deliverables across the drug development lifecycle.

Key Responsibilities

• Lead statistical programming activities for assigned compounds or therapeutic areas
• Create and validate ADaM datasets, TFLs in compliance with CDISC standards
• Develop and validate ISS and ISE for regulatory submissions
• Build, test, and maintain reusable SAS programs and macros
• Prepare reviewer guides, define.xml, and regulatory documentation
• Mentor and guide junior statistical programmers
• Collaborate closely with Biostatistics, CDM, Clinical, and Regulatory teams

Required Skills & Experience

• Strong hands-on experience in SAS programming (R experience is a plus)
• In-depth knowledge of CDISC standards (ADaM, SDTM)
• Experience supporting FDA / EMA regulatory submissions
• Understanding of clinical trial processes and data flow
• Exposure to therapeutic areas such as Oncology, Immunology, or Neuroscience
• Strong communication and leadership capabilities

Why Join Us?

• Work on global, cutting-edge clinical trials
• Be part of a high-impact data-driven environment
• Collaborate with experienced professionals in life sciences

Interested candidates can share their CVs at:

samiksha@latinumhr.com