Statistical Programmer - Hyderabad - Latinum HR Solutions

    Latinum HR Solutions
    Latinum HR Solutions Hyderabad

    8 hours ago

    ₹500,000 - ₹1,600,000 (INR) per year *
    Description

    Hiring: Statistical Programmer – Clinical Data Analyst | SDTM, ADaM & TLF

    Locations: Mumbai | Pune | Bangalore | Hyderabad | Delhi

    Industry: Pharma / Biotech / Clinical Research

    Experience: 3–12 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 & TFL)
    • 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

    * This salary range is an estimation made by beBee
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