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Job Details

PW-6744 Senior Manager, Statistical Programming

Company: AXESS
Reference: PW-6744
Closing Date: 09 Jan 17
Type: Permanent
Salary (£): Competitive
Benefits: Comprehensive

Job Summary:

This role at our Global Pharma client will support the Biostatistics team by providing statistical programming support for all US and UK Phase1 Biostatistics. This will be largely involved with creation and validation of derived data sets for modelling and simulation and will also include, but not be limited, to reviewing statistical analysis plans, clinical study report/integration.



  • Global Pharma company
  • Collaborative, friendly environment
  • European HQ based



Statistical Analysis Plans:

  • Reviews SAP, TLG shells and variable derivation rules and provides feedback

Clinical Study Report/Integration:

  • Develops programs for the creation and validation of datasets (SDTM & ADaM) and TLGs (This will be the main focus of the role).
  • Reviews the SAP, provides feedback to the statistician and develops (with the statistician) study specific datasets
  • Integrates multiple studies in support of an ISS/ ISE.
  • Supports ad-hoc, interim, exploratory, publications and performs programming and generates outputs
  • Maintains data, programs and reports in accordance with 21 CFR part 11

Modelling and Simulation:

  • Responsible for reviewing derived data set specifications for Modelling and Simulation
  • Develops programs for the creation and validation of derived data sets for Modelling and Simulation

Regulatory Interaction:

  • Creates / validates the eSubmission components (transport datasets for both SDTM & ADaM, Annotated CRF, define documents)



  • BS or MS in Relevant  Field
  • Experience in clinical development statistical programming methods and processes in industry setting required
  • Experience in phase I essential
  • Significant SAS programming experience
  • Thorough knowledge, understanding and experience of CDISC standards.


Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.



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-6744



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Apply for this job:  PW-6744 Senior Manager, Statistical Programming

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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