STATISTICIAN REQUIRED
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„h BE INVOLVED WITH A NEW FUNCTION WITHIN AN ESTABLISHED COMPANY
„h IMMEDIATE START
SALARY + BENEFITS Competitive Salary (up to 40K), Car Allowance, 24 days
Holidays + Bank Holidays, Pension, Bonus, Share Purchase Plan, Private
Healthcare, Life Assurance, Subsidised Dining.
BACKGROUND Our Client is a contract development organisation that provides
exploratory phase clinical development services (phase 1 & 2) for the
Pharma & Biotech industries.
Working as part of a small Clinical Data Management Team and reporting into
the head of the department, a new vacancy has been created for a
Statistician to provide statistical input into each trial Protocol and CRF
design through to writing sections of the final study report.
PRIMARY DUTIES
„h Review study concepts and give advice on the design of studies, paying
particular attention to whether the objectives can be met, the elimination
of sources of bias, the definitions of endpoints and major response
variables, and that the study is of adequate size on statistical grounds
„h Approves the study protocol
„h Prepare and review statistical analysis plans in agreement with the
relevant Study Director
„h Prepares suitable randomisation (for randomised studies)
„h Available to discuss statistical aspects of studies with Investigators
and Regulatory Authorities
„h Review and comment on proposed CRF design and agree with Clinical Data
Manager how data will be computerised
„h Before completion of the database, discusses and agrees on a Data
Validation Plan with the relevant Clinical Data Manager, SQL Programmer and
Study Director
„h Liaise with Clinical Data Managers regarding progress of study, likely
completion dates, known problems with the execution of the study including
deviations from the protocol
„h Perform statistical analysis with the aid of suitable statistical
software and write the statistical sections of the Integrated Clinical and
Statistical Study Reports, as well as any additional tables or graphs
required for the report or, if necessary, for publication
„h Write/follow appropriate SOPs for statistical activities
„h Keep informed of major relevant developments in statistical,
pharmaceutical and computing methodologies
„h Liaise with external vendors in relation to outsourced biometric work
QUALIFICATIONS
„h Degree in Biostatistics and/or Mathematics with 3 years relevant
experience.
„h Pharma or CRO experience
„h Good working knowledge of SAS (Version 6 or higher)
„h Knowledge of ClinTrial 4 would be beneficial but is not essential
ADDITIONAL INFORMATION This is a full time office based permanent position
based in Cambridgeshire. A relocation package is available to UK residents.
For a confidential discussion, please telephone Andy Smith at AXESS on 020
8560 2300. To apply, please send your CV to [log in to unmask], quoting
reference AS 1028.
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