Background:

Our client is a privately owned Ltd Company with the financial backing
of the 3rd largest chemical manufacturing companies worldwide. 

They have a large Phase II programme which is about to move into Phase
III.

This is an opportunity to work on European Multi-Country Trials (part of
Global Trials) and be responsible for the statistical needs of 

the company across all its activities.

A competitive salary will be offered as well as competitive benefits.

 

Primary Duties:

Oversee statistical aspects of clinical trials and non medical
activities at all stages of the compound's life cycle

Acting either on single projects or on a number of different pieces of
work in all stages of the lifecycle of the trial from design through to
analysis and reporting.

Represent the company concerning statistical matters in meetings or
discussions with regulatory agencies

Provide statistical input to study designs and analysis

Develop and write statistical analysis plans

Responsible for statistical analysis and appropriate programming for in
house projects and provide objective interpretation of results

Ensure that the case report forms capture the data in the format most
suitable for the statistical analysis 

Author and review statistical reports for inclusion into other
documentation

Develop and give presentations on statistical aspects of studies

Provide a statistical quality control service while studies are in
progress or reporting

Manage statistical activity budgets

Contributes to development work in relation to statistical analysis
standards and template development

Oversee the activities and performance of external vendors (e.g. CROs)
by

Represent the statistics function for assigned tasks on internal
Clinical Project Teams.

Participates in company process improvement and development initiatives.

Develop appropriate SOPs

 

Experience and Qualifications:

The role requires expertise in statistics and SAS programming with a
good understanding of the requirements for documentation content 

and format to ICH GCP standards.

A M.Sc. or higher degree in statistics

Minimum of 5-7 years experience of statistics in a clinical environment

Highly developed and proven knowledge of statistical principles, SAS
programming skills and clinical drug development in the pharmaceutical
industry 

knowledge of database and interface systems

Demonstrated success in the preparation of statistical reports

Excellent working knowledge of current statistical guidelines in the EU
and USA

Experience of working with/within CROs

Ability to work autonomously without appreciable supervision; providing
good organisation, prioritisation and communication skills with
demonstrable 

strong problem solving expertise.

Demonstrates flexibility to adapt quickly to changing plans and
priorities

Well-developed computer skills including proficiency in Word, Powerpoint
and Excel

Use of project management tools and graphics packages also desirable

Able & willing to travel [UK and abroad] (valid driving license
required).

 

Contact:

*          Christian Simon - Resource Executive

*          Tel: 020 8560 2300   

*          Send your CV quoting job ref StatsNW

*          AXESS Limited, Parkshot House, 5 Kew Road, Richmond, Surrey.
TW9 2PR

 

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*          This e-mail is confidential and may be legally privileged. If
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