Statistical Programmer

1 month ago

Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time
Join Fortrea as a Statistical Programmer

Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

About the Role

As a Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you will be central to the successful delivery of complex clinical trials (phases I-III) for renowned, innovative, and global top pharmaceutical companies. Your responsibilities will include developing and validating SAS and R programs for data presentations and analyses, as well as providing programming support to your multidisciplinary global project team.

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/define XML/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
  • Maintain awareness of industry standards, global regulatory requirements, internal guidelines, and Standard Operating Procedures (SOPs)
Requirements
  • Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
  • In lieu of the above: an equivalent completed vocational training and/or equivalent professional experience in statistical programming for clinical trials
  • Solid professional experience as a statistical programmer within a biotech, CRO, or pharmaceutical company
  • Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs
  • Programming experience in R is required
  • Proven professional experience with SDTMs, ADaM datasets (safety and efficacy), and TFLs
  • Solid knowledge of CDISC standards
  • Strong organizational skills, an autonomous and collaborative work style, a curious mind, and a keen attention to detail
  • Business fluency in English - both spoken and written - is a must
About Fortrea

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. We are proud to be an Equal Opportunity Employer and strive for diversity and inclusion in the workforce. We do not tolerate harassment or discrimination of any kind and make employment decisions based on the needs of our business and the qualifications of the individual.

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