Clinical Trials Statistical Programmer

2 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom MAI Fortrea Development Limited Full time

At MAI Fortrea Development Limited, we're looking for a skilled Statistical Programmer to join our Flexible Solutions business unit.

About the Role

As a Statistical Programmer, you will play a crucial role in the successful delivery of complex clinical trials for renowned pharmaceutical companies.

You will develop and validate SAS and R programs for data presentations and analyses, providing programming support to your global project team.

This position offers the opportunity to participate in the development of innovative new benchmark drugs for various therapeutic areas, including chronic and rare diseases.

Your expertise and work as a statistical programmer will have a direct impact on improving the health and lives of thousands of patients globally.

Key Responsibilities
  • Review SAPs and TFL shells from a programming perspective
  • Advise on the development of complex TFL shells from a programming perspective
  • Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets
  • Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs, and TFLs
  • Produce XML and PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTMs and ADaMs
  • Respond to QA and client audits and support qualification audits
  • Identify and propose innovative ways to improve the efficiency, quality, and productivity of our clinical statistical programming business
Requirements
  • Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
  • Professional experience as a statistical programmer within a biotech, CRO, or pharmaceutical company
  • Demonstrated knowledge of base SAS, SAS macros, SAS/STAT, and ability to debug SAS programs
  • Programming experience in R is required
  • Proven professional experience with SDTMs, ADaM datasets, and TFLs
  • Solid knowledge of CDISC standards
  • Business fluency in English – both spoken and written – is a must


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