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Job Details

Manager - Statistical Programming - Medical Device - UK

Company: Umbilical Life
Reference: JC73
Closing Date: 01 Dec 17
Type: Full Time
Salary (£): Competitive

Job Summary:

James Carrera of Umbilical Life is recruiting a Statistical Programming Manager to work with a Multi-Site Medical Device business. Call James on 0044 116 461 0070 or email



  • Attend multidisciplinary team meetings, representing the programming function.
  • Create or review and approve programming plans at study and project level.
  • Provide input on key study related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
  • Create or review and approve CDISC compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
  • Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
  • Assist statisticians by suggesting algorithms to address novel analysis requests
  • Develop software validation procedures and test plans, as necessary.
  • Create and document archives of software, outputs, and analysis files.
  • Create and maintain department SOPs related to clinical programming.
  • Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
  • Oversee work of internal contract programmers and external vendors.
  • Provide time and resource estimates for project planning.




  • Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields Master’s Degree preferred
  • 7 years of experience in developing software for clinical trials using the SAS system
  • Skilled in programming with SAS. Knowledge of additional programming languages a plus.
  • Good knowledge of statistics and drug development process
  • Experience as a lead programmer for NDAs/BLAs
  • Experience in pharmacokinetics/pharmacodynamics modelling a plus
  • Familiarity with CDISC standards, including SDTM and ADaM models
  • Solid verbal and written communication skills



As well as a competitive salary you will receive outstanding industry benefits including pension, life and medical insurance, car allowance etc.


For a confidential discussion please contact James Carerra at Umbilical

on +44 (0) 116 461 0070 or email

Apply for this job: Manager - Statistical Programming - Medical Device - UK

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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