Lead Clinical Trial Statistician

6 days ago

Madurai, Tamil Nadu, India beBeeBiostatistician Full time ₹ 15,86,160 - ₹ 25,14,924
Senior Biostatistician Role Overview

The Senior Biostatistician plays a crucial role in developing, implementing, and overseeing statistical strategies to support clinical trials. Guided by the Head of Biostatistics, this position contributes to planning, execution, and interpretation of statistical analyses across development programs.

This position is responsible for leading or contributing to study design discussions, including protocol development, endpoint definition, and sample size estimation. The Senior Biostatistician will oversee the execution of statistical analyses per SAP in collaboration with programming and CRO partners.

Main Responsibilities
  • Study Design and Execution: Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation.
  • Statistical Analysis: Oversee the execution of statistical analyses per SAP in collaboration with programming and CRO partners.
  • Quality Control: Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards.
  • Regulatory Interactions: Lead or support regulatory interactions on statistical issues, providing applicable statistical strategies to handle clinical and regulatory considerations.
  • Communication: Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed.

To be successful in this role, you should have a strong understanding of statistical methodologies and clinical trial designs. You should also have experience with regulatory support and interaction, as well as the ability to work independently with minimal supervision.

Requirements:

  • Masters degree or PhD in Biostatistics, Statistics, or related quantitative field.
  • Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; minimum 6 years for PhD-level candidates.
  • Proficiency in statistical programming in SAS; knowledge of R and other programming languages is preferred.
  • Solid knowledge of CDISC standards (e.g., SDTM, ADaM) and their application.
  • Experience with vendor oversight and managing CRO collaborations.
  • Proven ability to manage multiple studies and timelines concurrently.
  • Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians.

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