Statistical Programmer - Bengaluru - Latinum HR Solutions

    Latinum HR Solutions
    Latinum HR Solutions Bengaluru

    2 days ago

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

    Job Title: Statistical Programmer – Clinical Data (SAS/R)

    Location: Pan India

    Experience: 3 – 12 years

    Industry: Pharmaceuticals / Biotechnology / Clinical Research

    About the Role

    We are looking for an experienced Statistical Programmer to oversee programming activities for clinical trials, regulatory submissions, and integrated analyses. This role involves leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development.

    Key Responsibilities

    • Lead statistical programming activities for a compound or therapeutic area.
    • Manage, mentor, and guide a team of statistical programmers.
    • Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards.
    • Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports.
    • Ensure accuracy and consistency across clinical studies and integrated data.
    • Develop, test, and implement reusable standard programs and SAS macros to automate routine tasks.
    • Prepare reviewer guides, data definition documents, and other materials for regulatory filings.
    • Collaborate with cross-functional teams including Statisticians, Clinical Data Management, Medical Writing, Regulatory, and Clinical Operations.
    • Accurately estimate programming efforts and ensure timely project delivery.

    Required Skills

    • Strong proficiency in SAS programming; experience with R preferred.
    • In-depth knowledge of CDISC standards (ADaM, SDTM).
    • Experience with regulatory submissions (FDA, EMA) and clinical study lifecycle.
    • Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience.
    • Strong communication and leadership skills to guide teams and manage stakeholders.
    • Ability to handle multiple priorities and deliver high-quality results under deadlines.

    Why Join Us?

    • Work on cutting-edge clinical trials and regulatory submissions.
    • Collaborate with a team of top-tier professionals.
    • Opportunity to develop advanced programming frameworks and drive innovation in data analytics.
    * This salary range is an estimation made by beBee
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