Dear Allstat
Please find the latest permanent Senior Statistician based in the UK
Senior Statistician
The Position:
An opportunity has arisen for a Senior Statistician. You will be responsible for the biostatistical aspects of Clinical Development projects. On project level this includes development of strategies for clinical development plans with a 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. You will also be responsible for workflow and planning and monitoring resources.
Responsibilities:
Non drug development
Ensures that priorities are consistent with those of Biostatistics
Provides statistical advice and support to members of Biostatistics
Assists in ensuring that statistical standards and SOP's are followed within the Section
Assesses, recommends and develops new standards, policies and procedures.
Keeps abreast of statistical methodological developments through literature and attendance at meetings. Maintains familiarity with regulatory authority guidelines relating to Biostatistics and with medical issues in own project areas
Interacts with other departments, including Clinical Science, Regulatory Affairs, Project Management, etc., to ensure good coordination and communication
Assesses, develops and documents new methods and software
Makes presentations at professional forums
Drug development
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
Ensures that members of drug development team, clinical team and management understand the interpretation of the statistical methods applied to the project
Ensures consistency within project and as far as possible between projects. Assists in the development and maintenance of project standards. Documents agreed Biostatistics policies and procedures.
Plans and requests line management approval for resource allocation for statistical tasks.
Informs and makes recommendations to the Head of Statistics Section on critical issues within the project. Informs management of potential project delays and proposes solutions
Leads and manages statistical team if acting as project statistician
Ensures that activities performed within a study or project are executed in a timely manner and to the required high statistical and reporting standards
Responsible for the writing of the statistical section of the protocol, stating the hypothesis, defining the planned analysis, primary and secondary variables, time periods, interim analysis specifications, intent-to-treat population and explaining the statistical basis for the choice of sample size.
Writes statistical analysis plan. Ensures that statistical methods, programming algorithms, data presentations, output deliveries, and timing and load of work are sufficient detailed to execute the analysis smoothly
Checks appropriateness of planned analysis. Assesses impact of subjects withdrawn/lost to follow-up and deviations from planned trial design. Checks validity of distribution assumptions and impact of outliers. Documents methods and procedures used in the analysis and decisions made about data handling
Supervises, writes and assists in programming statistical outputs and their validation.
Participates in writing publications
For further information or to apply for this role send your details to Robert Whyte at James Harvard Pharmaceutical.
Email [log in to unmask] or you can call directly on +44 (0) 20 7922 7117
If this opportunity is not what you are looking for but are actively looking for a contract or permanent position as a Biostatistician or SAS Programmer then call for a confidential discussion.
Kind regards,
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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