Lead Statistician for Clinical Trials

3 weeks ago


Austin, Texas, United States Fortrea Full time
Senior Statistical Programmer

Fortrea, a global contract research organization, is seeking a highly skilled Senior Statistical Programmer to join our team. This permanent, remote opportunity can be worked from anywhere in the U.S. or Canada regions.

We offer a rewarding career, an opportunity to work in a high-energy, innovative & collaborative workplace, along with access to comprehensive benefits. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

About the Role
  • The ideal candidate will perform the role of Lead Statistical Programmer, planning, executing, and overseeing all programming activities on a study, including resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
  • This position involves developing and maintaining SAS programs to create SDTM and ADaM datasets and TFLs, performing QC of SDTM, ADaMs, and TFLs, producing Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers Guides to support SDTMs and ADaMs.
  • The successful candidate will develop specifications for SDTMs and ADaM datasets, review SAPs and TFL shells from a programming perspective for studies, mentor less-experienced programmers in the processes around SDTMs, ADaMs, and TFLs, present and share knowledge at department meetings, respond to QA and client audits, and support qualification audits.
Requirements
  • Bachelor's degree in mathematics, statistics, computing, life science, health science, or related subjects.
  • Typically 3-5 years of SAS programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience.
  • Knowledge of CDISC requirements and Oncology lead experience.
  • Submissions experience is preferred.
What We Offer

We provide a competitive salary range of $100,000 - $135,000 USD and a comprehensive benefits package, including medical, dental, vision, life, STD/LTD, 401(K), ESPP, paid time off (PTO) or flexible time off (FTO), and company bonus where applicable.



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