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Job Details

Senior / Principal Statistician

Company: AXESS
Reference: PW-6769
Closing Date: 18 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits: Comprehensive

Job Summary:

This is an opportunity for an experienced Statistician to join a global pharmaceutical company. Working within its European HQ where there is a focus on phase I programmes, the role will work with multi-functional teams to provide statistical advice and support on clinical drug development, trial design, analysis, report and responses to competence authorities. Work may also involve phase II within other regions.



Based in London, our client is a global pharmaceutical company which conducts early phase clinical development in Europe.



Works as a project statistician in multi-functional project teams. Main responsibilities include:

  • Provides statistical input in study design, analysis and reporting
  • Contributes to the development of study synopsis, protocol, (e)CRF design, study report and publications
  • Leads the development of statistical analysis plan and statistical report.
  • Performs or co-ordinates development and/or QC of analysis outputs
  • Represents the statistics function in multifunctional project teams to ensure statistics-related activities conducted by the project teams and CROs are consistent with statistics SOPs, guidelines and standards.
  • Provide statistical input to compound/indication overall clinical development plan
  • Participates in the evaluation and selection of external vendors.
  • Provides oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs from the study start-up through archiving.
  • Reviews and validates statistics related CRO deliverables
  • Contributes to the development and implementation of the internal/departmental standards and process improvements
  • Commit to their own professional development by attending regular training and conferences, keeping up to date with the latest industry techniques and regulations
  • Provides training to MTPE employees.



Qualifications / education required:

  • An MSc or a PhD or equivalent in biostatistics, statistics or mathematics.

Experience required:

  • Extensive experience gained as a statistician within a Pharmaceutical company, a Biotech or a CRO

Specialist training required

  • Good understanding of clinical study designs, statistical inferences and commonly used statistical methodologies
  • Good knowledge of EMEA/FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials
  • Comprehensive knowledge of the pharmaceutical industry including understanding of clinical drug development process and GCP requirements
  • Good skill of statistical programming languages including SAS

 Particular aptitude / skill required

  • Good project management skills
  • Excellent communication skills and ability to work with cross-functional teams
  • Excellent knowledge of clinical quality standards

Tools and equipment /software used

  • Common office software packages, Lotus Notes, e-mail, Internet, project management tools, SAS are essential, nQuery advisor, R are preferred.



For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to quoting reference PW-6769



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AXESS has been operating since 1990

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Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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