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Senior Statistical Programmer - Sponsor Dedicated
Fortrea
Remote, GBR
Full-time
Senior · 5+ years experience
Remote
Discovered 2 weeks ago
SASSAS MacrosSAS/STATCDISCSDTMADaM
Free
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SASSAS MacrosSAS/STAT
Key Skills for This Role
SASSAS MacrosSAS/STATCDISCSDTMADaM
Full Job Posting
Your 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).
Your Profile
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.
Learn more about our EEO & Accommodations request here .
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