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Job Details

PW-6744 Senior Manager, Statistical Programming

Company: AXESS
Location:
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.

Requirements:

BACKGROUND

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

 

PRIMARY DUTIES

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)

 

QUALIFICATIONS / EXPERIENCE REQUIRED

  • 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.

 

TO APPLY

For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW-6744

 

KEYWORDS

Statistical Programming, statistical programmer, Manager Statistical Programming, Senior Manager Statistical Programming, programming, programmer, Biostatistics, Hertfordshire, Cambridgeshire, Bedfordshire, Berkshire, Buckinghamshire, Essex, Hertfordshire, London, stats programmer, senior statistical programmer, temporary, SAS Programming, SAS programmer, contract SAS programmer, Clinical Programmer,

 

ABOUT AXESS

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.axess.co.uk

 

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

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Surrey
TW9 1AA
England
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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