Biostatistician

Organisation
Health Products Regulatory Authority (HPRA)
Locations

Dublin, Hybrid

Application Deadline
Salary
72,587

ROLE SUMMARY

The position of Biostatistician will be based in the Human Products Authorisation and Registration (HPAR) department and will report to the Technical Specialist Team Lead.

The Biostatistician will use their statistical expertise to review Marketing Authorisation and Clinical Trial Applications and advise on good drug development, interacting with medical colleagues and multi-disciplinary advisory committees and company representatives as required.

Key Responsibilities:

  • Working with the Technical Specialist Team Lead and other managers in the Clinical Assessment section to plan and organise work tasks that ensure efficient delivery of work
  • Assisting in the compilation of data and preparation of reports as required
  • Attending meetings of the HPRA Advisory Committees as required
  • Attending Working Groups/Committees/meetings at the European Medicines Agency (EMA), as required
  • Analyse and critically appraise statistical aspects of pre-marketing applications including dossiers for medicines, scientific advice applications and clinical trial applications, and preparing assessment reports. The assessment includes but is not limited to statistical methods, statistical design, statistical analyses plans, sample size, sensitivity analyses and imputation methods for missing data.
  • Liaising with assessment teams in the assessment of the above mentioned applications
  • Informing and influencing National and EU advisory and decision-making committees, including the Advisory Committee for Human Medicines (ACHM) and the Committee for Medicinal Products for Human Use (CHMP)
  • Contributing to the peer review of national and EU scientific evaluation documents
  • Providing statistical advice on behalf of HPRA to stakeholders such as investigators, sponsors, and others to ensure that any planned study/project results and conclusions are presented accurately and without bias

*full role profile available on the HPRA website

QUALIFICATIONS AND EXPERIENCE

To be considered for this post, candidates must have:

  • A postgraduate qualification (MSc/PhD) in statistics, biostatistics or related quantitative discipline
  • Knowledge and understanding of the drug development process (pre-clinical, quality, clinical and post-approval)
  • Sound understanding of basic statistical and clinical trial methodology relevant to the regulation of medicines
  • Experience and knowledge with statistical software packages
  • The ability to evaluate and critically appraise complex information from a variety of sources and make effective decisions
  • Effective problem-solving skills including the ability to anticipate problems and recognise when to involve other parties (at the appropriate time and level)
  • Strong organisational skills, including the ability to prioritise workload
  • The ability to work under pressure to tight timelines
  • Excellent oral and written communication skills
  • The ability to work as part of a cross-functional team and clearly communicate statistical issues and methods to both statisticians and non-statisticians
  • Excellent attention to detail

In addition, the following would be considered an advantage:

  • Work experience in applying statistical methods in biomedical research, pharmaceutical or CRO industry or drug regulatory agency
  • Ability to quickly develop a sound understanding of a wide range of statistical and clinical trial methodology, including state-of-the-art techniques, relevant to the regulation of medicinal products across the breadth of the drug development process
  • Knowledge of regulatory (ICH, EMA and FDA) guidelines

CLOSING DATE FOR APPLICATIONS

The closing date for applications for this post is 11th August 2024.


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