Senior Statistical Programmer

0 years

0 Lacs

Posted:1 day ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Lead Statistical Programmer

Key Responsibilities:

  • Author, validate, and document

    SAS programs

    for datasets, TFLs, and macros, applying good programming practices.
  • Develop and maintain programs in

    R

    , with hands-on experience in packages such as

    Tidyverse, Admiral,

  • Create

    ADaM datasets using Admiral packages

    in R.
  • Read and write raw data across

    SAS and R

    platforms.
  • Conduct thorough

    debugging

    using R console tools.
  • Review and approve clinical trial documents,

    dataset specifications

    , and

    TFL shells

    .
  • Identify and resolve data issues, outliers, and standards-related discrepancies.
  • Complete, review, and approve

    CDISC Validation Tool

    reports.
  • Stay updated on

    emerging CDISC standards

    and assess impacts on ongoing and future trials.
  • Maintain proficiency in SAS and awareness of developments in programming tools and standards.
  • Ensure all study master file documents are

    audit-ready

    .
  • Serve as

    Lead Programmer

    on client accounts and projects, managing client expectations and providing issue resolution.
  • Provide input into and review of

    project management documents

    .
  • Perform all work in full compliance with applicable

    legislation, regulations, company policies, and procedures

    .
  • Actively contribute to internal and client

    study team meetings

    .

Qualifications & Skills:

  • Bachelor’s or Master’s degree in

    Statistics, Computer Science, Life Sciences

    , or a related field.
  • Proven experience in

    SAS programming

    within clinical trials or pharmaceutical/CRO settings.
  • Strong hands-on experience with

    R programming

    and relevant packages.
  • Knowledge of

    CDISC standards

    (ADaM, SDTM) and regulatory submission requirements.
  • Excellent problem-solving, debugging, and data validation skills.
  • Strong communication skills to manage client interactions and cross-functional collaboration.
  • Ability to work independently as well as lead project teams.

Preferred Experience:

  • Exposure to

    regulatory submissions

    and audit processes.
  • Experience as a

    Lead Programmer

    managing timelines, deliverables, and client relationships.

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