> Dear Allstat,
> 
> Please find to follow the job description for a Statistician position that I'm recruiting for.
> 
> My client is a world leader in their field; renowned for excellence and innovation. Their beautiful rural setting makes this a fantastic lifestyle choice as well as a career move into a respected organisation.
> 
> As well as a challenging day-to-day job, the post holder will 
> 
> Please contact me with CVs (quoting reference AIB1001696 in the subject field) if you'd like to express an interest in this role.
> 
> Kind regards,
> 
> Adam Isle 
> Manager 
> HUDSONSHRIBMAN 
> s c i e n t i f i c r e c r u i t m e n t 
> T: +44 (0)20 7269 0900 
> F: +44 (0)20 7404 5773 
> E: [log in to unmask] 
> W: www.hudson-shribman.co.uk 
> 
STATISTICIAN, c£30-£35K+Benefits, South East/East Anglia, Ref: AIB1001696

Purpose of the Role:

To provide statistical input throughout each clinical trial, including Protocol and CRF design, the randomisation of studies, analysis of clinical data and writing sections of the final study report.

Interfaces:

Clinical staff, Data Management and IT departments.
External contact with Statistical Analysis providers and collaborators e.g. CROs and Site Personnel.

Key Tasks & Responsibilities:

Management.
 
To co-ordinate contact and management of ongoing statistical analysis outsourced to external biometrics providers.  To review the technical content of materials received from external biometrics providers.  Keeps up to date with own job and external factors i.e. changes in regulatory requirements.  

Accountability Area:

To provide input throughout the study design, management of clinical data and analysis of phase I clinical data.  Responsibility to follow procedures in accordance with SOPs.  

Autonomy & Authority:

Direct authority over statistical input into Clinical Data Management, PCD and BH project teams.  Autonomy for decision making within Clinical Data Management, PCD and BH project teams according to SOPs.
 
Functional Knowledge:

An understanding of Clinical Data Management/Statistical input into clinical studies performed at the site.  Demonstrates a thorough understanding of Clinical Data Management/Statistical processes and procedures and associated quality systems.  A good understanding of how the team and Study Management function integrates with others functions to achieve overall objectives.  

Business Expertise:

Awareness of business environment and impact of individual and team actions.  An understanding of the organizational structure within the Study Management function and the PCD matrix.
Leadership:

Collaborate within the team by contributing actively and fully to projects.  Encourages positive mental attitude and working relationships. Ability to work in multi-functional teams. As required, train new team members.

Problem Solving:

To offer a proactive approach to identifying and solving problems associated with providing statistical input into clinical studies.  To encourage a solution oriented approach to problem solving, and to use initiative.  Ability to use judgement based on analysis of available information. Ability to re-organise and prioritise at short notice.  Identifies relevant information and assesses the impact of decisions on Clinical Data Management, the project team and other effected functions.

Nature & Area of Impact:

To contribute to the success of all clinical trials by providing effective statistical input to agreed deadlines and maintaining expected levels of quality.  Demonstrate an awareness of quality requirements. To initiate new procedures and improvements to existing processes to maximise the efficiency of the role and the quality of deliverables.

Interpersonal Skills:

Good team player, with excellent communication skills, who can work to deadlines, is flexible and enjoys a dynamic team environment.  Communication skills include the ability to deal with different types of internal/external customers and internal contacts to meet project objectives in the most effective and efficient way, maintaining excellent relationships for the long term.  Demonstrates well developed leadership skills and the ability to 'see the bigger picture'.  Remains focused, positive and adaptable to unexpected demands.  Show tenacity and determination in completion of tasks.  Performs in an organized, accurate and methodical manner.

Special Projects:

Able to take on projects within the function or within clinical research outside of the area of Clinical Data Management.

Responsibilities:

Reviews study concepts and gives advice on the design of studies, paying particular attention to whether the objectives can be met, the elimination of sources of bias, the definitions of endpoints and major response variables, and that the study is of adequate size on statistical grounds. 

Approves the study protocol. 

Prepares and reviews statistical analysis plans in agreement with the relevant Study Director. 

Prepares suitable randomization (for randomized studies).

Available to discuss statistical aspects of studies with Investigators and Regulatory Authorities. 

Review and comment on proposed CRF design and agrees with Clinical Data Manager how data will be computerized.

Before completion of the database, discusses and agrees on a Data Validation Plan with the relevant Clinical Data Manager, SQL Programmer and Study Director.

Liaise with Clinical Data Managers regarding progress of study, likely completion dates, known problems with the execution of the study including deviations from the protocol. 

Performs statistical analysis with the aid of suitable statistical software and writes the statistical sections of the Integrated Clinical and Statistical Study Reports, as well as any additional tables or graphs required for the report or, if necessary, for publications. 

Maintains complete and up-to-date documentation of the study in accordance with relevant SOPs. When the study is no longer active, performs the necessary work for archiving all documentation, computer programs and data files. 

Reviews protocols, study reports and publications as requested by the Head of Study Management. 

Write/follow appropriate SOPs for statistical activities.

Keeps informed of major relevant developments in statistical, pharmaceutical and computing methodologies.

Liaise with external vendors in relation to outsourced biometric work.

To provide appropriate training

Candidate's Profile:

Eduction/ Professional Experience. 

Degree in Biostatistics and/or Mathematics. At least three years experience in a statistician role within Clinical Research (Industry or CRO).  Sound working knowledge of SAS, version 6 or higher.  Knowledge of Clintrial v4 (useful).

Languages:

English essential.  Italian/French useful.

To Apply:
 
If you would like to be considered for this role, please contact Adam Isle, Manager at Hudson Shribman Scientific Recruitment, quoting reference AIB1001696, outlining your particular skills and experience and their relevance to this post. 

Please call on 020 7269 0900, or reply via email, entering the job title and reference code in the subject field to:
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