Dear Allstat
Please find the latest permanent Senior Statistician for a London based global Pharmaceutical company.
Senior Statistician
The purpose of this position is to provide program-level statistical expertise by:
* Designing, analyzing and interpreting clinical studies and programs conducted by TGRD (US and EU).
* Standardizing study design, analysis methodology and presentations to maximize global data integratability.
* Leveraging external vendors providing statistical services to achieve quality, timely, cost-effective study deliverables.
ACCOUNTABILITIES:
* Represent the statistics function in support of clinical studies led from either the US or EU.
* Provide statistical input to feasibility assessments, development and submission plans, and defence of regulatory submissions.
* Provide accurate, statistically appropriate outputs included in protocols, statistical analysis plans, study reports and regulatory submission documents.
* Implement project level database (including derived database), analysis and reporting standards.
* Plan and direct study-level analysis and reporting activities including work of other programmers.
* Identify study-level vendor requirements and participate in the evaluation/selection of BDM vendors. Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
* Anticipate and communicate resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
* Contribute to increasing efficiency of the Statistics function through development of standard analysis methodology, data presentations and sharing of best practices. Support implementation of such standards and process improvements.
* Comply with all applicable regulatory requirements and standards and procedures.
* Perform other duties as assigned.
EDUCATION, EXPERIENCE AND SKILLS:
* PhD in statistics or biostatistics with minimum of 2 years of relevant experience or MS in statistics or biostatistics with minimum of 3 years of relevant experience.
* Knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, and data presentation practices.
* Knowledge of the pharmaceutical industry including understanding of clinical drug development process and documents.
* Knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
* Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office* products).
* General project management skills.
* Good oral and written communications skills.
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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