Senior Biostatistical Consultant

5 days ago

Dublin, Dublin City, Ireland beBeeBiostatistician Full time

We are seeking a skilled Biostatistician to join our team.

Job Description:

Overview:

The ideal candidate will have a strong background in biostatistics and experience working on clinical trials. They will be responsible for providing statistical support, developing statistical plans, and analyzing data.

Key Responsibilities:

  • Liaise with cross-functional teams to drive the quality of statistical planning, analysis, and reporting.
  • Serve as a resource for the department, ensuring scientific integrity and regulatory compliance.
  • Participate as lead statistician on major projects, contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, and preparing/reviewing integrated clinical and statistical reports.

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.
  • 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.

About Us:

We are a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.

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