Clinical Trials Biostatistician Leader

18 hours ago

Kannur, Kerala, India beBeeSeniorBiostatistician Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title: Senior Biostatistician

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About the Role: The Senior Biostatistician will lead and develop statistical strategies, deliverables and oversee planning, execution and interpretation of statistical analyses across development programs.

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  • As a Biostatistics leader, you will contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation.
  • You will author and review Statistical Analysis Plans (SAPs), including mock tables, figures and listings (TFLs).
  • Biostatistics leadership is required for assigned studies and projects; you will lead or contribute to study design discussions.
  • You will provide statistical input and review for clinical study reports, regulatory documents, and publications.
  • A key responsibility is performing quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards.
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Responsibilities:

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  • Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations.
  • Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed.
  • Stay current with emerging statistical methodologies and evolving clinical trial practices.
  • You are expected to perform other duties/tasks as required or assigned.
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Requirements:

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  • A Master's degree or PhD in Biostatistics, Statistics or related quantitative field, required.
  • Minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 6 years for PhD-level candidates.
  • Proficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferred.
  • A strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application.
  • Experience with regulatory support and interaction required.
  • Ability to communicate statistical concepts clearly and effectively.
  • Able to work independently with minimum supervision.

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