Senior Statistical Programmer – Sponsor Dedicated

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🕒 January 13

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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.

🎯 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. • Business fluency in English – both spoken and written – is a must.

🏖️ Benefits

• Flexible work arrangements • Professional development opportunities