As a Senior Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials (phases I-III) for renowned, innovative and global top pharmaceutical companies. Oftentimes you will have the opportunity to lead studies through various phases of the clinical development plan and support submissions, regulatory questions, publications as well as ad hoc and post hoc requests.
In this role, you will develop and validate SAS programs for data presentations and analyses and provide programming support to your multidisciplinary global project team. This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas. Your expertise and your work as a statistical programmer have a direct impact on improving the health and lives of thousands of patients around the globe every day.
You can be 100% home-based or if you prefer, you can work from our local office in your home country.
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.
Skills Required
- 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; ability to debug SAS programs.
- Proven professional experience with SDTMs, ADaM datasets and TFLs.
- Solid knowledge of CDISC standards.
- Business fluency in English - both spoken and written.
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
