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Global drug and device development services

Senior Biostatistician 1 / 2

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A Master's degree or Ph.D. in Biostatistics, Statistics, or a related field is required.
  • At least 6 years of biostatistical experience in a contract research organization, pharmaceutical company, or biotech company is required.
  • Experience leading Phase II–III studies, including client-facing responsibilities, timeline management, and resource oversight, is required.
  • Regulatory experience supporting and handling regulatory requests, such as New Drug Application applications, is required.
  • Advanced ability to plan, supervise, implement, and monitor statistical processes for multiple clinical studies is required.
  • Effective written and oral communication skills and demonstrated leadership ability are required.
  • Ability to prioritize and strong time management skills are required.

Responsibilities

  • Serve as lead biostatistician for programs of studies, submissions, or individual studies ranging from simple to complex.
  • Oversee statistical activities supporting ICON's interactions with clients and regulatory agencies.
  • Review and approve statistical methods sections of study protocols, statistical analysis plans, and statistical input to reports.
  • Program inferential statistics using SAS and/or R.
  • Prepare and approve research proposals and budgets for statistical consulting and statistical analyses for clients.
  • Participate in bid defense meetings and present at marketing meetings with prospective clients.
  • Mentor or provide support to junior statisticians.
  • Lead or participate in initiatives to improve internal processes or create new guidance.

Desired Qualifications

  • Experience working in a clinical research organization is preferred.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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