> Dear Allstat
> Please find below the latest permanent Statistician vacancy in the East Anglia.
> For further details please contact Robert Whyte for a confidential conversation on 0207 922 7117 or submit your CV to [log in to unmask]
>
statistician
Basic Purpose and objective:
To act as the lead statistician on selected single projects. To support the lead statistician on projects, by providing statistical input into clinical trials from design, through analysis and reporting. To support the lead statistician on projects, by providing statistical input into clinical trials from design, through analysis and reporting. To provide statistical programming support for data summaries and listings, and validation programming support in the production of statistical appendices. To represent the Biostatistics department within the company and with interactions with client companies and regulatory agencies, as required.
Duties and Responsibilities
* Be familiar with and follow the departmental and company standard operating procedures (SOPs) and working practices (WPs).
* Serve as a lead statistician on selected single projects.
* Ensure projects are well documented consistent with company SOPs and working practices.
* Time management of own and team's time spent on projects.
* Interact with the sponsor on statistical aspects of the project.
* Produce sample size calculations. Provide input into study design and statistical considerations, during protocol development. Review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contribute to writing appropriate protocol sections.
* Provide randomization schemes and appropriate documentation, on selected projects.
* Develop statistical analysis plans, including table, listing and graph specifications.
* Specify the general structure of the analysis database, provide programming support for its development and validation.
* Produce statistical analyses and statistical appendices, with appropriate documentation.
* Validate statistical analyses and statistical appendices, with appropriate documentation.
* Prepare Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy and other documents, as required. Contribute statistical methods section for Integrated Clinical Statistical Reports.
* Review Integrated Clinical Statistical Reports.
Qualifications:
BSc degree in statistics or related field. Advanced degree (MSc) is desirable.
Skills and knowledge:
Strong knowledge of statistical principles underlying clinical trials, and strong statistical skills.
SAS programming skills, familiarity of other statistical packages and understanding of database structures.
Familiarity with ICH Statistical and reporting guidelines and GCP.
Good organizational skills of own work load, with the ability to adapt and adjust to changing priorities.
Excellent written and verbal communication skills.
Ability to work in a multi-disciplinary team setting.
Positive attitude and the ability to work well with others.
Experience:
A minimum of 1 years experience in statistics in a clinical research environment
> Robert Whyte
> Consultant ~ Clinical & Biometrics Division
> James Harvard Pharmaceutical Ltd
>
> T. 020 7922 7117 M. 07957 190569 F. 020 7922 7101
> E: [log in to unmask]
> W: www.jamesharvardpharma.com
>
> 25 > -> 27 Wootton Street : Waterloo : London : SE1 8TG
>
> We are exhibiting at the 2006 annual PSI conference Stand 3 from 15-17 May 2006.
>
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