> Dear Allstaters,
>
> Please find below our latest Statistics role.
>
> My client is actively looking for a Biostatistics Manager with a minimum 10 years experience of statistics in a clinical trial environment. You will be managing a team of 15 statisticians and statistics programmers, organizing work load across the team and report project status to management. You will be required to perform a project management and line management function within the Biostatistics department and to oversee the statistical aspects of clinical trials from design, through analysis and reporting, acting as the lead statistician on multiple projects. To represent the Biostatistics department within the company and with interactions with client companies and regulatory agencies.
>
>
> Duties and Responsibilities include:
>
> * Manage the training and implementation of departmental procedures for the Biostatistics team.
> * Serve as a lead statistician on multiple projects.
> * Ensure projects are well documented consistent with company SOPs and working practices.
> * Manage a project team for multiple protocols. This involves conducting team meetings, maintaining
> project timelines, assessing resource need, providing resources, and budget management. Ensure that SOPs
> are being followed and that appropriate project documentation is ongoing.
> * Provide Project Management on Biostatistics only projects.
> * Allocate and co-ordinate resources within the team to achieve timelines, time management of own and team's
> time spent on projects.
> * Interact with the sponsor on statistical aspects of the project and present at meetings as required.
> * Provide the Project Manager, Biostatistics department and company management with timely, accurate
> status and resourcing reports.
> * 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.
> * Manage the development of statistical analysis plans, including table, listing and graph specifications.
> * Organize the production of statistical analyses and statistical appendices, with appropriate documentation.
> * Ensure that appropriate validation for statistical analyses and statistical appendices is implemented.
> * Manage the preparation and review of 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.
> * Manage the Quality Review of the statistical reporting of selected projects.
> * Manage a team of statisticians and statistics programmers by promoting employee development, completing
> performance reviews, planning and documenting development and training.
> * Mentor members of the department, providing project guidance and statistical advice.
> * Monitor progress of projects within Biostatistics, reporting status to departmental and company management.
> * Provide input to management as to hiring recommendations, department policies, and resourcing
> requirements.
> * Assist in bidding and business development activities, as required.
>
>
> Skills and knowledge: Strong knowledge of statistical principles underlying clinical trials and strong statistical skills.
> SASŪ programming skills and familiarity of other statistical packages (e.g. StatXact, Nquery) and understanding of database structures.
> Good organizational skills across multiple projects, managing own and team work loads. The ability to adapt and adjust to changing priorities.
> Excellent written and verbal communication skills.
> Ability to work in a multi-disciplinary team setting.>
> Demonstrated initiative, motivation and problem solving skills.
> Positive attitude and the ability to organise a team and work well with others.
> Evidence of strong management skills, as shown through management of multiple projects and team members.
>
>
> For more information or for a confidential career discussion please don't hesitate to contact me to discuss this exciting opportunity.
>
>
>
> Mark O> '> Brien
> Consultant ~ Clinical & Biometrics
> James Harvard Pharmaceutical Ltd
>
> T. 020 7922 7106 M. 07921 176225 F. 020 7922 7101
> E: [log in to unmask]
> W: www.jamesharvardpharma.com
>
> 25 > -> 27 Wootton Street : Waterloo : London : SE1 8TG
>
>
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