Senior Statistical Programmer, Clinical Trials

24 hours ago


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

We are seeking a highly skilled Senior Statistical Programmer to join our team at Fortrea, a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. As a Senior 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.

Key Responsibilities
  • Develop and validate SAS programs for data presentations and analyses
  • Provide programming support to your multidisciplinary global project team
  • Develop and 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
  • 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.
  • 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
  • Proven professional experience with SDTMs, ADaM datasets (safety and efficacy), and TFLs
  • Solid knowledge of CDISC standards
  • Submission experience is ideal
About Us

Fortrea is a 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. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.



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