Bio Statistician

6 - 11 years

20 - 25 Lacs

Posted:2 hours ago| Platform: Naukri logo

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Full Time

Job Description


Job Description: Biostatistician

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Role Summary

Biostatistician

Key Responsibilities

  • Develop

    Statistical Analysis Plans (SAPs)

    for clinical trials
  • Perform statistical analyses for

    Phase IIV clinical studies

  • Support

    protocol design

    , sample size calculations, and randomization
  • Analyze safety and efficacy data using appropriate statistical methods
  • Review and validate

    Tables, Listings, and Figures (TLFs)

  • Partner with statistical programming teams using

    SAS and/or R

  • Provide statistical inputs for

    Clinical Study Reports (CSRs)

  • Support regulatory submissions and responses to health authorities
  • Ensure compliance with

    ICH-GCP, FDA, and EMA

    guidelines
  • Participate in cross-functional review meetings with clinical and medical teams

Required Skills & Qualifications

  • Master’s or PhD in

    Biostatistics, Statistics, Mathematics, or related field

  • 6 - 12 years of experience in a

    Pharmaceutical or Clinical Research company

  • Strong expertise in

    SAS and/or R

  • Solid understanding of

    clinical trial design and statistical methodologies

  • Experience with

    CDISC standards (SDTM, ADaM)

  • Knowledge of survival analysis, regression, mixed models, and hypothesis testing

Preferred Skills

  • Experience working directly with

    clinical development teams

  • Therapeutic area exposure (Oncology, CV, CNS, etc.) is a plus
  • Strong documentation and regulatory submission experience
  • Ability to clearly communicate statistical concepts to stakeholders

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