SAS Statistical Programmer II - Hyderabad - vueverse.

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    vueverse. Hyderabad

    1 day ago

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    Description

    Senior Statistical Programmer

    Location: Hyderabad

    Experience: 8+ Years

    Domain: Clinical Research / Biostatistics / Life Sciences

    Role Overview

    We are seeking two experienced Senior Statistical Programmers with deep expertise in CDISC standards (SDTM & ADaM) and TLF generation to support global clinical trials. The role involves end-to-end programming support across study start-up, conduct, submission, and regulatory interactions.

    Key Responsibilities

    1. CDISC Programming

    • Develop and validate SDTM datasets in compliance with CDISC standards.
    • Create and quality-check ADaM datasets aligned with SAP and regulatory requirements.
    • Ensure traceability between raw data, SDTM, ADaM, and TLF outputs.
    • Perform generation and validation (if applicable).

    2. TLF (Tables, Listings, Figures)

    • Program and validate Tables, Listings, and Figures as per SAP specifications.
    • Generate efficacy, safety, PK/PD, and exploratory outputs.
    • Perform independent validation and QC of statistical outputs.

    3. Regulatory & Submission Support

    • Support NDA/BLA/MAA submissions (FDA/EMA/PMDA preferred).
    • Address regulatory queries related to datasets and outputs.
    • Ensure compliance with ICH, GCP, and CDISC guidelines.

    4. Study-Level Ownership

    • Lead programming activities for assigned clinical studies.
    • Provide timelines, effort estimates, and risk mitigation plans.
    • Collaborate with Biostatistics, Data Management, and Clinical teams.
    • Mentor junior programmers (if applicable).

    Technical Skills Required

    • Strong expertise in SAS programming (Base SAS, SAS/STAT, SAS Macro).
    • Hands-on experience in:
    • SDTM implementation
    • ADaM dataset creation
    • TLF programming
    • Experience in Pinnacle 21 validation.
    • Knowledge of generation tools.
    • Exposure to oncology, immunology, or rare disease studies preferred.
    • Understanding of submission-ready datasets.

    Qualification

    • Bachelor's/Master's in Statistics, Biostatistics, Mathematics, or related field.
    • 8+ years of statistical programming experience in clinical trials.
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