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Associate Director of Biostatistics

Boston, MA
  • Full-Time
Job Description
Great opportunity to join a global Biopharmaceutical company with a strong pipeline and a portfolio of proprietary commercial products.

Associate Director, Biostatistics

Position Summary:
The Associate Director of Biostatistics will support drug development activities and decision-making for Phase I-IV studies. This includes guidance on study design, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results.

Duties and Responsibilities:
  • Work with a group of biostatisticians to develop and execute statistical strategy, design, and analyses for clinical trials focuses on Oncology, Psychiatry, or Neurology using appropriate and innovative statistical methods
  • Effectively interact with members in other functions including medical, regulatory, safety, clinical operation, and translational medicine for strategic planning to ensure optimized clinical development in accordance with corporate objective
  • Provide statistical input to project team and senior management.
  • Provide statistical input and content in support of regulatory interactions and submissions- briefing books, and integrated summary documents.
  • Effectively coordinate statistical endeavors with outside organizations, CROs and consultants
  • Provide guidelines and standards to CROs and internal programing team to ensure quality of deliverables
  • Identify and implement emerging new ways of doing clinical development and new methodologies
  • Participate in department initiatives and research forums

Basic Requirements:
  • Ph.D. in Statistics or Biostatistics
  • 5+ years of clinical research and drug development experience

Preferred Requirements:
  • Recent experience working in the field of Oncology, Psychiatry, or Neurology is a plus
  • In-depth knowledge of methodologies applied in clinical trials with focus on registration and life-cycle management
  • Experience of interactions with regulatory agencies- US and Non-US is a plus
  • Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development



Boston, MA



Posted date

Over a month ago
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