Senior Biostatistical Expert

1 day ago

Dublin, Dublin City, Ireland beBeeBiostatistician Full time €96,700 - €123,456
Job Title: Biostatistical Expert

This Biostatistical Expert will provide statistical support for projects in the Vaccines Therapeutic Area. The qualified candidate will collaborate with project/study teams and provide statistical expertise in designing research concepts, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, writing/reviewing reports, and publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries.

Key Responsibilities:

  • Provide scientifically rigorous statistical input on post-hoc / ad-hoc analysis requests in support of publication projects and regulatory query responses.
  • Develop statistical analysis plans, mock-up tables, and quality check plans.
  • Oversee programming support activities for assigned projects.
  • Validate the accuracy, consistency and integrity of the statistical output displays generated by programmers.
  • Lead multiple project teams by applying project management skills, statistical and programming techniques to prepare, execute, report, and document high-quality statistical analyses per statistical analysis plans.
  • Conduct peer review of project-related work performed by other statisticians, maintain compliance with the latest regulatory requirements, and maintain project documentation and files according to departmental policy.
  • Communicate competently and independently with the client to coordinate the statistical and programming considerations of the project.
  • Demonstrate a strong understanding of ICH guidelines and clinical trial design as applicable to statistics.

Requirements:

  • Masters in Statistics/Biostatistics (or related field) with 8+ years' experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with 4+ years' experience in clinical trials.
  • Effective verbal and written communication skills.
  • Understanding of broad statistical theory and its application.
  • Able to fully understand clinical questions and concepts and translate them into SAP development followed by data generation all the way through publication.
  • Effective at clearly explaining statistical concepts to colleagues without statistical training.
  • Work collaboratively as a team member.
  • Experience with statistical modelling of clinical data and statistical inference.
  • Experience in R or SAS programming languages.

What We Offer:

  • Competitive salary.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, offering 24-hour access to a global network of professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits.

Our Culture:

  • We're dedicated to providing an inclusive and accessible environment for all candidates.
  • We're committed to providing a workplace free of discrimination and harassment.

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