Biostatistician

CPL

Dublin City Centre

Biostatistician, New opportunity with my client. Fantastic opportunity to join this dynamic organisation. This is a new role within a new department with great scope to progress. ROLE SUMMARY. The position of Biostatistician 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. The Biostatistician will work closely and maintain effective working relationships with other members of the Clinical Assessment section, and with members of the other departments as a whole, to ensure effective co-ordination and co-operation across all areas of assessment and to ensure that the objectives of the department are met. The Biostatistician will maintain effective working relationships with colleagues in other sections and departments to ensure that issues requiring cross-functional input are conducted effectively and followed up on. KEY RESPONSIBILITIES. - Strategic Objectives o Supporting the Clinical Assessment Manager and other managers in the Clinical Assessment section in the on-going development of the section. Working with the Clinical Assessment Manager and other managers in the Clinical. Assessment section in the preparation of work objectives for the section. o Providing support and input to colleagues and others within the Clinical Assessment section. Assisting in the compilation of data and preparation of reports as required. Attending meetings of the Advisory Committees as required. Attending Working Groups/Committees/meetings at the European Medicine Agency. (EMA), as required. Attend meetings with other Irish Agencies, as required. Attend meetings at the European Pharmacopoeia, as required Maintaining appropriate records of meetings and activities o Attending and contributing to meetings of the Clinical. o Providing support to other colleagues within the department, where required. - Technical Objectives o The analysis and critical appraisal of statistical aspects of pre marketing application including dossiers for medicines, scientific advice applications and clinical trial applications, and the preparation of 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. o Represent the organisation at relevant National and EU meetings, when required. o Maintain and enhance personal and technical competence by keeping abreast of new statistical methodology, occasional analysis of data and other personal development activities. o Contribute to and assist in the delivery of teaching technical staff on clinical statistics o Providing data analysis to support policy direction, and other functions as may be determined depending on the needs of the organisation. o Assisting the Clinical Assessment Manager and other managers in the Clinical Assessment section in ensuring the accuracy of relevant data inputted in the computer databases and information systems. - Quality and Knowledge Management o Assist the managers of the Clinical Assessment section to ensure the effective implementation of the Quality Management System within the section. o Assist the managers of the Clinical Assessment section to ensure that there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge gained by the section. o Assist the managers of the Clinical Assessment section to ensure that available information and knowledge is effectively used by the section. o Assist the managers of the Clinical Assessment section to ensure that procedures remain up to date with relevant developments in National, European and International regulations, legislation and guidelines. QUALIFICATIONS AND EXPERIENCE. - To be considered for this post, candidates should meet the following criteria: o Have a Master or PhD in Biostatistics or Statistics with significant experience in clinical trials methodology. o Knowledge and experience of drug development (clinical and post-approval) and understanding drug development as a continuum o Experienced with ICH GCP, regulatory (e.g. EMA and FDA) guidelines. Sound understanding of a wide range of statistical and clinical trial methodology, including the most up-to-date techniques available that are relevant to the regulation of medicines, as employed across the breadth of the drug development process. o Significant work experience in the design, analysis and interpretation of randomised, controlled clinical trials across all stages of clinical development and in a wide range of therapeutic areas. o The ability to evaluate complex information from a variety of sources and make effective decisions. o Effective problem solving skills, proven critical appraisal skills, including the ability to anticipate problems and recognise when to involve other parties (at the appropriate time and level. o Experience and knowledge with statistical software packages. o Demonstrate strong organisational skills, including the ability to prioritise workload o Ability to work under pressure to tight timelines. o Good strategic ability (including problem solving, critical thinking skills and thinking crossfunctional. o Excellent oral and written communication skills. Ability to work as part of a cross-functional team and clearly communicate statistical issues and methods to both statisticians and nonstatisticians. o Excellent attention to detail. - In addition, the following would be considered an advantage; o Experience in medical informatics. o Work experience in applying statistical methods in biomedical research, pharmaceutical or. CRO industry or drug regulatory agency o Experience in methodological issues associated with observational research. For further details contact Tina at +353 1 2784671 or email your cv in confidence to tdunne@thornshaw.com. For a list of all active vacancies log on to www.thornshaw.com. This job originally appeared on RecruitIreland.com.

2320 days ago