This role is for upcoming future opportunities that may arise at Fortrea.
As a Statistical Programmer II 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.
You can be 100% home-based or if you prefer, you can work from our local office in your home country.
Your Responsibilities:
With sufficient experience assume the role of a Lead Statistical Programmer for CP studies only with support from senior programming staff.
Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviews Guides to support SDTMs and ADaMs.
With support from senior programming staff, develop specifications for SDTMs and ADaM datasets.
Review SAPs and TFL shells from a programming perspective for studies with support from senior programming staff.
Respond to QA and client audits with support from senior programming staff.
And all other duties as needed or assigned.
Your Profile:
Minimum Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.
Typically, 1 - 2 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Knowledge of CDISC requirements.
Business fluency in English – both spoken and written – is a must.
Learn more about our EEO & Accommodations request here
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators.
Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas.
Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes.
Together, exceptional is possible.
Learn more at Fortrea.com
