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Clinical Biostatistician - Galway

  • Sector: Medical Devices
  • Contact Email: amy.newell@collinsmcnicholas.ie
  • Job Ref: 19160

An exciting opportunity has arisen with a leading diagnostics client who are looking for an experienced Clinical Statistician to join their team based in Galway. This role will offer the opportunity for hybrid working.


The role of the Clinical Statistician is to provides a wide range of advanced statistical expertise, guidance, and support to Clinical Affairs team engaged in R&D and Clinical studies. The Clinical Statistician participates in the design, development, and reporting of Clinical studies and R&D research projects.

 

RESPONSIBILITIES

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Designs, plans and executes 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, prepares the statistical component of protocol which meet project objectives, health authority guidelines, and clinical trial methodology standards.
  • Develops and/or applies statistical theories, methods, and software.
  • Organizes and interprets 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.
  • Performs miscellaneous job-related duties as assigned.

 

EDUCATION AND COMPETENCIES REQUIRED

  • Master's degree or equivalent experience preferred .
  • Typically requires 4+ years of relevant work experience to develop the competence to demonstrate and fulfill the duties and responsibilities of the position.
  • Experience with regulations and standards affecting the medical diagnostic industry.
  • Experience with or exposure to Good Clinical Practices.
  • Ability to clearly, concisely and accurately convey communications.
  • Ability to form and develop interpersonal, professional relationships;   displays socially and professionally appropriate behaviour.
  • Good Knowledge of statistical techniques and experimental design.
  • Proficient in SAS programming, preferably SAS certified.
  • Solid understanding of the clinical Research process with Good knowledge of EU and FDA regulatory. requirements, as well as ICH/GCP guidelines is preferred.
  • 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 a more detailed and confidential discussion on this role contact Amy Newell.

amy.newell@collinsmcnicholas.ie

091-706718