Project Biostatistician - £40,000 plus benefits
Purpose
· To co-ordinate the design, statistical analysis and reporting of
clinical studies in clinical development programs
· To represent Biostatistics on Clinical stud Teams (CSTs)
Reports (at a minimum) to:
Associate Biostatistics Manager
Responsible for:
Ensuring that all statistical elements of study-related documentation meet
standards and are statistically correct
Key Activities
Participate in the internal peer review process within Biostatistics Europe
for protocols, Statistical Analysis Plans (SAPs), Clinical Study Reports
(CSRs), publications and posters
Fulfil role of Clinical Study Team (CST) Biostatistician:
· Participate in CST meetings
· Lead and project manage all CST statistical activities
· Create statistical text for study concept documents and protocols
· Draft SAPs
· Draft and/or review and approve Biostatistics filenotes
· Participate in and make statistical presentations at investigator
meetings
· Review and approve study planning documents and other related study
documents (eg Case Report Forms (CRFs), Data Management Plans (DMPs), PD
Definitions, Monitoring Plans etc) from statistical perspective
· Review and approve randomisation lists (dummy and finalized)
· Conduct and/or review and approve Biostatistics User Acceptance
testing of study databases
· Draft and/or review and approve Case Report Tabulation (CRT) dataset
specifications
· Write, test, validate and execute software programs to produce CRT
datasets and Tables of Listings Graphs (TLGs), related to statistical
analysis and description of data, for inclusion within Clinical Study
Reports (CSRs), Integrated Summary of Safety / Integrated Summary of
Efficacy (ISS / ISE), publications and posters
· Participate in the finalisation of PDs and analysis sets and approve
database freeze
· Unblind, load and check accuracy of treatment assignment data
· Create statistical text for CSRs, publications and posters
· Plan and execute statistical review and Quality Control (QC) of
CSRs, publications and posters
Qualifications
· BSc in Mathematics (or other degree with high statistical content)
· MSc in Statistics
Experience
· Statistical Analysis
· Minimum 3 years in Pharmaceutical / Biotechnology / Contract
Research Organisation (CRO) Industry
· Clinical Development
· Fundamentals of project planning and management
· Communication of statistical information
· International co-operation
· Team Working
Knowledge
· Statistical methodology and applications within clinical trials
· Clinical development process and operations
· English
Competencies
· Scientific / Technical Excellence
· Oral and written communication
· Team Work
· Attention to detail
· Project Management
Gemma Skillett
Senior Consultant
Pharmaceutical Division
Blue Pelican IT
Tel: 01580 20 16 16
Fax: 01580 20 20 00
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URL: www.bluepelicanit.com
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