Our client, a national regulatory body are currently recruiting for a Biostatistician to join their team. In this role, you will use your statistical and professional expertise to lead the assessment and review of the statistical aspects of marketing authorisation applications and clinical trial applications. You will critically analyse complex clinical and scientific information, making sound judgements on the value of the statistical methodologies employed, and write informative assessment reports for a multi-disciplinary readership. You will provide expertise on good drug development, interacting with medical colleagues, multi-disciplinary advisory committees and company representatives and will provide in-house statistical expertise to other technical sections in the organisation. This role offers hybrid working-two days per week in the Dublin office and three days working from home.
Responsibilities
Analyse and critically appraise statistical aspects of pre-marketing applications including dossiers for medicines, scientific advice applications and clinical trial applications and prepare assessment reports. Assessment includes, but is not limited to, statistical methods, statistical design, statistical analyses plans, sample size and sensitivity analyses and imputation methods for missing data
Liaise with assessment teams in the assessment of the above-mentioned applications
Inform and influence National and EU advisory and decision-making committees
Provide advice to the organisation and to National or EU scientific committees
Contribute to the peer review of national and EU scientific evaluation documents
Provide statistical advice on behalf of the organisation to stakeholders such as investigators, sponsors, and others to ensure that any planned study/project results and conclusions are presented accurately and without bias
Represent the organisation at relevant National and EU meetings, when required
Maintain and enhance personal and technical competence by keeping abreast of new statistical methodology
Contribute to and assist in the delivery of statistical training and knowledge sharing
Provide data analysis to support policy direction, and other functions as may be determined depending on the needs of the Strategic Objectives of the organisation
Support the Section Manager, and Section Leadership Team in the on-going development of the section
Provide support and input to colleagues and others within the Section and the department
Participate in shaping the organisation, strategic visioning, developing the business, innovating and creating Operational Objectives
Requirements
A postgraduate qualification (MSc/PhD) (NFQ level 9 or 10) in statistics, medical statistics or biostatistics
A relevant 3rd level honours degree (NFQ level 8) in mathematical, life science, or healthcare discipline (e.g. mathematics/applied mathematics, biostatistics, statistics, biomedical science, pharmacology, pharmacy, genomics, psychology)
A minimum of two years relevant experience in applying statistical methods in drug regulatory agency, biomedical research, pharmaceutical or CRO industry, or an additional post graduate qualification (NFQ level 10) in statistics, medical statistics or biostatistics
Experience employing analytical thinking on complex data and statistics, and ability to make appropriate and tailored recommendations, comprehensible by multidisciplinary audience
Have a sound understanding of statistical methodology relevant to the regulation of medicines and clinical trials, and emerging methodologies relevant to the field of statistics and medicines regulation
Knowledge and understanding of the drug development process (pre-clinical, quality, clinical and post-approval) with understanding of drug development as a continuum
Knowledge and understanding of the clinical trial process, different clinical trial designs and various statistical approaches that may be used
Experience and knowledge with statistical software packages, standard office software (Word, Excel, PowerPoint), cloud-based platforms (Microsoft Teams) and communication tools (Outlook)
Ability to evaluate and critically appraise complex information from a variety of sources and make effective decisions
Self-starter, accountable, capable of effective communication, negotiation and decision making
Strong organisational skills, including the ability to prioritise workload
Excellent oral and written communication skills, excellent attention to detail
Passion for knowledge sharing and dissemination of statistical expertise, and a willingness to contribute to peer-to-peer learning.
The ability to work as part of a cross-functional team and clearly communicate statistical issues and methods to multidisciplinary audiences
In addition, the following would be considered an advantage
Experience in applying statistical methods in biomedical research, pharmaceutical or CRO industry or drug regulatory agency
Motivated 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 and experience of centralised licensing and clinical trials regulatory processes
*A more comprehensive role profile can be provided upon request*
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