Biostatistician, Clinical Assessment

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Job Description

We are actively sourcing Biostatistician candidates on behalf of ur client. 

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 multidisciplinary advisory committees and company representatives as required.

The Biostatistician will work closely and maintain effective working relationships with a more senior Biostatistician, with other members of the Clinical Assessment section, and with members of the department 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 of the Company, to ensure that issues requiring cross-functional input are conducted effectively and followed up on.

KEY RESPONSIBILITIES

Strategic Objectives
Supporting the Clinical Assessment Manager and other managers in the Clinical Assessment section in the on-going development of the section within the Human Products Authorisation and Registration (HPAR) department
Working with the Clinical Assessment Manager and other managers in the Clinical
Assessment section in the preparation of work objectives for the section
Working with the Clinical Assessment Manager and other managers in the Clinical Assessment section to prioritise work objectives and to ensure that the operational goals of the section are achieved
Providing support and input to colleagues and others within the Clinical Assessment section and the HPAR department

Operational Objectives
Working with the Clinical Assessment Manager 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 Advisory Committees as required
o Attending Working Groups/Committees/meetings at the European Medicines Agency o (EMA), as required
o Attending meetings with other Irish Agencies, as required
o Maintaining appropriate records of meetings and activities o Attending and contributing to meetings of the Clinical Assessment section and HPAR department
o Providing support to other colleagues within the department, where required

o Technical Objectives

o o 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
o Liaising with assessment teams in the assessment of the above-mentioned applications o 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) o Contributing to the peer review of national and


QUALIFICATIONS AND EXPERIENCE

o 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)
o Strong organisational skills, including the ability to prioritise workload
o The ability to work under pressure to tight timelines o Excellent oral and written communication skills
o The ability to work as part of a cross-functional team and clearly communicate statistical issues and methods to both statisticians and non-statisticians
o Excellent attention to detail

o In addition, the following would be considered an advantage:
o Work experience in applying statistical methods in biomedical research, pharmaceutical or o CRO industry or drug regulatory agency
o Work experience in the design, analysis and interpretation of randomised controlled clinical trials across different stages of clinical development and/or a range of therapeutic areas
o 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
o Knowledge of regulatory (ICH, EMA and FDA) guidelines o Expertise in the design and analysis of early-phase and/or adaptive clinical trials

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Full job spec on request. For further details contact Tina at +33 1 2784671 or email your CV to tdunne@thornshaw.com www.thornshaw.com

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Tina Dunne

Recruitment Manager 01 2784671 tdunne@thornshaw.com
  • Salary:Negotiable
  • Location:Dublin City Centre
  • Type:Permanent
  • Category:Science,Thornshaw
  • Ref.no:JO-2005-449910_16