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Senior Statistical Programmer, Clinical Trials
2 months ago
As a Senior Statistical Programmer at Fortrea, you will play a crucial role in the successful delivery of complex clinical trials for renowned pharmaceutical companies. With a strong background in statistical programming and a passion for data analysis, 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.
We are committed to revolutionizing 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.
