I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info





Connect with me on
Hot Science Jobs
Senior Design Engineer
Dublin
Utilities Engineer - Black Utilities
Roscommon
CTO
Galway
Engineering Business Manager
Dublin
R&D Manager
Connaught
R&D Technician II
Galway
Operations Excellence Lead
Louth
R&D Engineer
Galway
R&D Manager
Dublin
Product Development Manager
Galway
Product Development Technician
Galway
Project Engineer - Senior
Cavan
Senior Mechanical Engineer
Dublin
Senior Project Engineer
Cavan
Quality Director
Galway
Senior Electronic Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Product Application Specialist (IVD) - I
Dublin
Principal Equipment Engineer
Dublin
Upstream Manufacturing Process Specialis
Cork
Engineering Projects Lead
Carlow
Quality Technician
Dublin
Principal Equipment Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Process Support Specialist
Carlow
Injection Moulding Engineer
Athlone
Operations Manager
Galway
Senior Quality Control Associate
Dublin South
R&D Engineer
Dublin
Senior R&D Project Manager
Galway
Associate R&D Engineer
Galway
Senior Regulatory Specialist
Cork
Head of R&D
Galway
Quality Specialist & Deputy RP
Limerick
Senior R&D Engineer
Dublin
R&D Manager
Athlone
Senior Design Engineer
Dublin
Quality Assurance Engineer
Longford
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Equipment Engineer
Dublin
Quality Assurance Specialist (Shift)
Carlow
R&D Manager
Athlone
Business Systems Director
Louth
Responsible Person (RP)
Republic of Ireland
Senior Quality Engineer
Leitrim
Principal Software Engineer
Athlone
Engineering Shift Technician
Dublin
Injection Molding Engineer
North Leinster
Senior QC 24/7 Shift
Dublin
R&D Manager
Galway
R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
EHS Officer
Dublin
Cleaning Validation Specialist
Cork
R&D Manager
Galway
Principal Equipment Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Quality Specialist
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Process Chemist
Limerick
Senior R&D Engineer
Dublin
QC Bioanalytical Analyst
Dublin North
Quality Specialist
Clare
Operations Engineer
Galway
Principal Engineer
Dublin
Account Manager UK and Ireland
Republic of Ireland
R&D Project Manager
Galway
Senior Research and Development Engineer
Galway
Project Engineer
Roscommon
Project Manager - R&D
Galway
Senior Manufacting Engineer
Republic of Ireland
Senior Project Manager - Process Develop
Cork
Product Development Engineer
Dublin
Senior Electronics Engineer
Dublin
R&D Engineer
Dublin
Quality Engineer
Galway
R&D Engineer
Galway
Design Assurance Program Manager
Galway
Injection Moulding Engineer
Leitrim
Manufacturing Technician
Clare
R&D Engineer
Galway
Principal Process Equipment Engineer
Dublin South
Process Safety Specialist
Tipperary
Scientist (hybrid)
Meath
Electronic Engineer
Dublin
Senior R&D Engineer
Galway
Senior Clinical Project Manager
Dublin
Senior Design Assurance Engineer
Clare
R&D Engineer
Galway
Product Development Engineer
Galway
Principal Engineer
Dublin
R&D Engineer
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Principal Process Development Engineer
Galway
CTO
Dublin
Quality Systems Specialist
Tipperary
Senior Equipment Design Engineer
Dublin
QA Operations Specialist (hybrid)
Meath
Manufacturing Technician
Clare
Principal Quality Engineer
Galway
Associate R&D Engineer
Galway
QA Manager
Canada
Senior Regulatory Affairs Specialist
Clare
Maintenance CMMS Engineer
Tipperary
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Regulatory Specialist
Cork
Associate R&D Engineer
Galway
Senior Operations Engineer
Galway
Senior Electronic Engineer
Dublin
Senior Process Development Scientist
Dublin
Quality Engineer
Galway
MS&T Scientist Specialist
Meath
Quality and Regulatroy Manager
Galway
Quality Specialist
Clare
Senior R&D Engineer
Galway
Quality Systems Specialist
Tipperary
R&D Engineer
Clare
Manufacturing Engineer
Galway
Lead Chemistry Analyst
Cork
Cleaning Validation Specialist
Cork
R&D Manager
Connaught
Product Development Engineer
Dublin
R&D Manager
Connaught
Microbiology Manager
Dublin
Senior QA Associate (Shift)
Dublin
Principal Engineer - R&D
Galway
Senior Manufacturing Engineer
Galway
Project Manager - R&D
Galway
Production Operator
Carlow
QA Engineer
Leitrim
Compliance Specialist
Carlow
Quality Manager
Galway
R&D Engineer
Galway
Project Engineer
Limerick
Graduate Manufacturing Technician
Kilkenny
Senior Regulatory Affairs Specialist
Athlone
Product Development Engineer
Dublin
Quality Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Validation Engineer
Athlone
Project/Process Engineer - Purification
Cork
Senior Associate Quality Control NPI
Dublin
Senior Project Engineer
Cavan
Principal Preclinical Scientist
Galway
Principal Process Development Engineer
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Clare
Operations Engineer
Galway
Project Manager
Galway
QA Manager
Canada
Senior Regulatory Affairs Specialist
Athlone
Principal Engineer - R&D
Galway
Senior R&D Engineer
Galway
Principal R&D Engineer
Dublin
Senior Recruitment Consultant
Republic of Ireland
Notified Body Product Assessor -Active D
Canada
Principal/Senior R&D Engineer Cathet
Galway
Principal Equipment Engineer
Dublin
EHS Specialist
Meath
R&D Technician
Galway
Electronic Engineering
Dublin
Maintenance Technician
Carlow
R&D Formulation Chemist
Dublin
Reliability Engineering Consultant - Rem
Republic of Ireland
R&D Program Manager
Dublin
NPI Process Engineer
Carlow
Principal Device Engineer
Dublin
R&D Manager
Connaught
R&D Director
Galway
Cleaning Validation Specialist
Cork
Sr. Associate - Quality for Computer Sys
Cork
Facilities Engineer
Carlow
Manufacturing Engineer
Wexford
R&D Engineer
Galway
E&I Turnover Engineer
Carlow
Principal Equipment Engineer
Dublin
MS&T Associate Director
Dublin
Senior Electronics Engineer
Limerick
Mechanical Design Engineer
Germany
Quality Engineer
Galway
Senior Design Assurance Engineer
Galway
Senior Validation Engineer
Dublin
Quality Manager - Medical Devices
Limerick City
R&D Director
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Business Development Manager (Hospitals
Dublin
Senior Recruitment Consultant
Republic of Ireland
Principal Scientist Device and Product P
Dublin
R&D Manager
Galway
Quality Manager
Dublin
Electronic Engineer
Dublin
R&D Director
Galway
Electronic Engineer
Dublin
Senior Polymer Development Engineer
Galway
Product Development Engineer II
Athlone
Electronic Engineer
Dublin
Electronic Design Engineer
Galway
R&D Manager
Galway
Quality Control Technician
Carlow
Product Development Engineer
Dublin
Advanced Technologies R&D Manager
Clare
R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Technical Life Cycle & Engineering M
Galway
Senior Technical Transfer Specialist
Cork
Project Manager - R&D
Galway
Electronic Engineer
Dublin
Product Development Manager
Galway
Senior Quality Engineer
Dublin
Biostatistician
Dublin City Centre
Regulatory Affairs Specialist
Cork
Quality Control Technician
Carlow
Project Engineer
Clare
Senior Regulatroy Affairs Specialsit
Galway
Process Simulation Technical Engineer
Carlow
Project Manager Design Assurance
Galway
Product Development Engineer II
Athlone
Applications Scientist
Dublin
VP of Operations
Dublin
Senior QC Microbiology (Shift)
Dublin
Electronic Engineer
Dublin
Senior R&D Engineer
Dublin
Mechanical Technician - 2 Cycle
Carlow
Senior Analytical Specialist
Limerick
Quality Systems Manager
Dublin
Senior Engineering Manager
Limerick
Quality Manager
Galway
R&D Engineer
Galway
Clinical Research Associate
Cork
Investigation Lead
Dublin
Senior Operations Engineer
Galway
R&D Senior Program Manager
Galway
Maintenance Reliability Engineer
Tipperary
Senior R&D Manager - Lifecycle Manag
Galway
Senior Design Assurance Engineer
Athlone
Senior Manager Bioanalytical QC Lab
Limerick
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Biostatistician


Reference:SCABEA455845 Location: Dublin City Centre
Qualification:MastersExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Biostatistician

Biostatistician
Our client, a large regulatory body, are currently recruiting for a Biostatistician to join their team. As Biostatistician you will use yourstatistical expertise to review Marketing Authorisation Applications and advise on good drug development.


Responsiblites

  • Analyse and critically appraise 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
  • Liaise with assessment teams in the assessment of the above mentioned applications
  • Inform and influence National and European advisory and decision-making committees, including the Commission on Human Medicines (CHM) and the Committee for Medicinal Products for Human Use (CHMP)
  • 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
  • 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, occasional analysis of data and other personal development activities
  • Contribute to and assist in the delivery of statistical training to the organisations staff
  • Provide data analysis to support policy direction, and other functions as may be determined depending on the needs of the organisation
  • Assist the the Technical Specialist Team Leadand other managers in the Clinical Assessment section in ensuring the accuracy of relevant data inputted in the computer databases and information systems of the organisation

Requirements
  • Have a Masters or PhD in Biostatistics or Statistics with significant experience in clinical trials methodology
  • Knowledge and experience of drug development (clinical and post-approval) and understanding drug development as a continuum
  • 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.
  • 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.
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]