Senior Statistical Programmer, Clinical Trials

1 month ago

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

As a leading global contract research organization (CRO), Fortrea provides 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.

Your Role

In this role, you will develop and validate SAS programs for data presentations and analyses, and provide programming support to your multidisciplinary global project team. This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas, including chronic and rare diseases. Your expertise and work as a statistical programmer has a direct impact on improving the health and lives of thousands of patients around the globe every day.

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
  • Proven professional experience with SDTMs, ADaM datasets (safety and efficacy), and TFLs
  • Solid knowledge of CDISC standards
  • Submission experience is ideal
  • 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

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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