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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Biostatistician


Reference:SCAURR-266312 Location: Galway
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Biostatistician, Clinical Data Manager

Clinical Biostatistician
Our client, a global diagnostics organisation are currently recruiting for a Clinical Biostatistician to join their team on a permanent basis. As Clinical Biostatistician you will be responsible for a wide range of advanced statistical expertise, guidance, and support to Clinical Affairs team engaged in R&D and Clinical studies.



Responsibilities

  • Design, plan and execute biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of IVD products
  • In development-phase projects, prepare the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards
  • Develop and/or apply statistical theories, methods, and software
  • Organize and interpret data into tabular forms amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used
  • Provides specifications and directions to the clinical programmers
  • May partner in program design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Requirements
  • Master's degree or equivalent experience preferred
  • 4+ years of relevant work experience
  • Experience with regulations and standards affecting the medical diagnostic industry
  • Solid understanding of the clinical Research process with Good knowledge of EU and FDA regulatory requirements, as well as ICH/GCP guidelines is preferred
  • Good Knowledge of statistical techniques and experimental design
  • Proficient in SAS programming, preferably SAS certified. Solid understanding of the clinical Research process
  • Ability to coordinate statistical activities for a clinical study
  • Experience in CDISC standards with strong analytical and problem solving skills.
  • Excellent organizational skills, detail-oriented, efficient and able to multi-task and prioritize
  • effectively
  • Excellent interpersonal skills with strong written and verbal communication skills

For more information please contact Sinéad Cullen on +353879500821 or [email protected]