Quantitative Analyst

7 days ago

Ahmedabad, Gujarat, India beBeeBiostatistician Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Senior Biostatistician Role

This role involves leading the development, implementation, and oversight of statistical strategies and deliverables in support of clinical trials.

The Senior Biostatistician will contribute to the planning, execution, and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.

Key Responsibilities:
  • Serve as biostatistics leader for assigned studies and projects.
  • Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation.
  • Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings.
  • Oversee and ensure the execution of statistical analyses per SAP in collaboration with programming and CRO partners.
  • Provide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables.
  • Regularly communicate project status to management and escalate issues or risks in a timely manner.
  • Provide statistical input and review for clinical study reports, regulatory documents, and publications.
  • Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards.
  • 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.

Required Skills and Qualifications:

  • Bachelor's degree in Biostatistics, Statistics, or related quantitative field.
  • A minimum of 8 years of experience in clinical trial biostatistics; however, this may be reduced for candidates with a PhD.
  • Proficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferred.
  • Solid knowledge of statistical methodologies and clinical trial designs.
  • Strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application.
  • Experience with regulatory support and interaction.
  • Experience providing statistical oversight of vendors and managing CRO collaborations.
  • Proven ability to manage multiple studies and timeline concurrently.
  • Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians.
  • Ability to work as a team and have skills to convince your position within cross-functional teams.

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