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Statistical Programmer II – Multi Sponsor
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Job Summary
Lead studies and support submissions, regulatory questions, and publications as a Statistical Programmer II in a multi-sponsor business unit
Skills
English fluencySAS programmingCDISC requirements
Description
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As a Statistical Programmer II in our multi sponsor 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
#LI-AA3
#LI-Remote
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize 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. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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