Fortrea is seeking a Statistical Programmer to join our team at our clinical research facility in Leeds, UK. This is an office-based role supporting a diverse portfolio of Phase I clinical studies across multiple sponsors and therapeutic areas. Working in a fast-paced and collaborative environment, you will play a key role in the programming and delivery of clinical trial data, contributing to high-quality study outputs from study start-up through reporting.
This position offers the opportunity to gain broad exposure to different study designs, sponsors, and therapeutic areas while working closely with biostatistics, data management, clinical operations, and other cross-functional teams. The successful candidate will develop and maintain SDTM and ADaM datasets, produce statistical outputs, and contribute to the efficient delivery of clinical pharmacology studies, with opportunities for growth towards study lead responsibilities as experience develops.
Summary of Responsibilities:
- With sufficient experience assume the role of a Lead Statistical Programmer for CP studies only with support from senior programming staff.
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviews Guides to support SDTMs and ADaMs.
- With support from senior programming staff, develop specifications for SDTMs and ADaM datasets.
- Review SAPs and TFL shells from a programming perspective for studies with support from senior programming staff.
- Respond to QA and client audits with support from senior programming staff.
- And all other duties as needed or assigned.
Qualifications (Minimum Required):
- Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.
- Experience and/or education plus relevant work experience, equating to a Bachelor's degree.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
- Typically, 1 - 2 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
- Knowledge of CDISC requirements.
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