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Senior Statistical Programmer, Clinical Trials Expert
2 months ago
As a Senior Statistical Programmer at Fortrea, you will play a critical role in the successful delivery of complex clinical trials for renowned pharmaceutical companies. With a strong background in statistical programming and a passion for innovation, you will develop and validate SAS programs for data presentations and analyses, and provide programming support to your global project team.
Key Responsibilities- Review and advise on the development of complex TFL shells from a programming perspective
- 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
- Produce XML and PDFs, Analysis Results Metadata (ARM), 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
- Degree in a relevant field such as mathematics, life sciences, statistics, or computer sciences
- Solid 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
- Proven professional experience with SDTMs, ADaM datasets, and TFLs
- Solid knowledge of CDISC standards
- Submission experience is ideal
- Strong organizational skills, autonomous and collaborative work style, curious mind, and keen attention to detail
- Business fluency in English – both spoken and written – is a must
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. 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.
