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	Job detail
Client
Job Description	Statistician
Location	Cheshire
Salary	Neg.
Contact	info@jobs4europe.co.uk
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JOB PURPOSE:

 

To work on European Multi-Country Trials (part of Global Trials) and be responsible for the conduct or oversight To conduct and manage the medical writing needs of the Company across all its activities, ensuring the documentation meets required standards and contains appropriate information.

 

DIMENSIONS:

 

Reports to:                   Clinical Programme Manager (CPM)

 

Direct Reports:  None

 

PRINCIPAL ACCOUNTABILITIES:

 

• 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
  • Defining statistical analysis  requirements (i.e. tasks and deliverables) for studies that would be outsourced.
  • Be involved in the evaluation of CRO proposals and provide recommendations for selection.
  • Review Contract/Financial related documentation and provide updates to Senior Management as required.
  • Assist/Partake in Project Meetings organised by CRO.
  • Review and approve medical writing plans from CRO ensuring that they meet the requirements for the study.
  • Act as an interface between Ineos and the CRO and provide regular study updates to clinical team.
  • Regularly review Project Plan(s) and receive study updates from CRO on progress towards deliverables.
  • Assess progress, identify issues and review proposed solutions from CRO for appropriateness.
  • Receive regular updates from CRO on project resourcing and quality issues that impact on deliverables or timelines. Evaluate solution and as required, escalate to Senior Management if not appropriate with proposals.
• Represent the statistics function for assigned tasks on internal Clinical Project Teams.
• Participates in company process improvement and development initiatives.
• Develop appropriate SOPs

 

Other requirements:

 

·                To be office based

·                This role may also involve supporting the USA team if required

 

 

SPECIAL FEATURES

 

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, applicable competency in this field through self study and supported company training programmes.

 

 

KNOWLEDGE/EXPERIENCE/SKILLS NEEDED

·                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).