> Dear Allstat
> Please find below the latest PERMANENT Project Statistician vacancy in the UK.
> For further details please contact Robert Whyte for a confidential conversation on 0207 922 7117 or submit your CV to [log in to unmask]
>
The Project Statistician is responsible for the statistical aspects of Clinical Development projects. On project level this includes development of strategies for clinical development plan with clinical team and interaction with clinical/statistical experts. On study level this includes protocol contributions, case report form definition, scheduling of analyses using the Data Reporting Analysis Manual to help maintaining consistency across the project and finally conducting analyses to providing objective interpretation of results and defence of statistical decisions to clinical team, Life Cycle Team and regulatory health authorities. He/She organizes the workflow and plans and monitors resources.
Some of the principal functional accountabilities are listed below:
Non drug development
* Ensures that priorities are consistent with those of Biostatistics and provides statistical advice
* Assesses, recommends and develops new standards, policies and procedures and works to SOP's
* Keeps abreast of statistical methodological developments through literature and attendance at meetings. Maintains familiarity with regulatory guidelines relating to Biostatistics and with medical issues in own project areas.
* Assesses, develops and documents new methods and software
* Participates in and contributes to internal training programs
* Makes presentations at professional forums
Drug development
* Provides high quality statistical support to clinical projects
* Gives input and ensures that drug development strategy, protocols, CRFs and clinical registration documents are in line with ICH and health authority guidelines as well as company internal SOPs and guidelines. Reviews and approves protocols, CRFs and clinical
registration documents. Pays special attention to all statistical issues
* Participates in the preparation of drug development plans, especially the clinical development part, and proposes realistic deadlines for statistics tasks
* Provides high quality statistical support to clinical projects
* Gives input and ensures that drug development strategy, protocols, CRFs and clinical registration documents are in line with ICH and health authority guidelines as well as company internal SOPs and guidelines. Reviews and approves protocols, CRFs and clinical
registration documents. Pays special attention to all statistical issues
Who you are:
* MSc (or equivalent) or PhD in Statistics or very similar area.
* At least 8 years pharmaceutical industry experience in Biostatistics and clinical drug development
* Comfortable with Computers; can readily learn new software applications
* Experience in using statistical software (particularly SAS) as well as knowledge of database and interface systems
* Travel may be required
* With an exciting and growing pipeline of new products in development, we need more exceptional individuals to be part of our future
* Quite simply, there has never been a better time to join Roche - or to enjoy the exceptional levels of personal responsibility we offer
> 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 from 14-17 May 2006.
>
>
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