Statistical Leader

20 hours ago

Dublin, Dublin City, Ireland beBeeBiostatistician Full time €90,000 - €120,000
Job Overview

This role involves working with cross-functional teams to drive high-quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. As a Principal Biostatistician, you will serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials.

You will participate as lead statistician on major projects, contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.

Key Responsibilities:
  • Leadership:
  • Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the organization
  • Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee
  • Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication
  • Participate as high-level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries, and/or NDA sections
  • Leading studies at an operational level
  • Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures
  • Consult on operational/statistical/therapeutic area topics
Requirements:
  • Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry
  • Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials
  • Expert in strategically collaborating with clinical and drug development experts
  • Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries
  • In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Strong working knowledge of SAS or R
  • Excellent knowledge of CDISC Data Standards
  • Superb communication and collaboration skills
  • Independent and pro-active problem-solving skills

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