On behalf of our client, we are currently recruiting for a Biostatistician. This is a 3 year contract role initially with view to permanent. The role is a hybrid position with min 2 days a week in Dublin office.
ROLE SUMMARY 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 Assisting in the compilation of data and preparation of reports as required.Analysing and critically appraising 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 to stakeholders such as investigators, sponsors, and others to ensure that any planned study/project results and conclusions are presented accurately and without bias.Representing the company at relevant National and EU meetings, when required.Maintaining and enhancing personal and technical competence by keeping abreast of new statistical methodology, occasional analysis of data and other personal development activities.Contributing to and assisting in the delivery of statistical training.Providing data analysis to support policy direction, and other functions.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.For full details contact Linda at +353 1 2784701 or email your CV to ******. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
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