Biostatistician - Clinical Assessment – Human Products Authorisation and Registration

Closing date for applications: 17/06/2020

ROLE SUMMARY

The position of Biostatistician will be based in the Human Products Authorisation and Registration(HPAR) department and will report to the Clinical Assessment Manager.

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

QUALIFICATIONS AND EXPERIENCE

To be considered for this post, candidates must have:

o A postgraduate qualification (MSc/PhD) in statistics, biostatistics or related quantitative discipline
o Knowledge and understanding of the drug development process (pre-clinical, quality, clinical and post-approval)
o Sound understanding of basic statistical and clinical trial methodology relevant to the regulation of medicines
o Experience and knowledge with statistical software packages
o The ability to evaluate and critically appraise complex information from a variety of sources and make effective decisions
o Effective problem solving skills including the ability to anticipate problems and recognise when to involve other parties (at the appropriate time and level)

Applications should be submitted via the HPRA Recruitment Portal.


Role Profile            HPRA Recruitment Portal Application Form 




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