Senior Clinical Data Analyst

1 week ago


Durham, North Carolina, United States Fortrea Full time
Company Overview:
Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and clinical development expertise. With operations in over 90 countries, Fortrea offers pharmaceutical, biotechnology, and medical device customers a wide range of solutions across more than 20 therapeutic areas.

Salary:
$120,000 - $155,000 USD

Job Description:
The Principal Statistical Programmer will play a crucial role in planning, executing, and overseeing programming activities on studies. This includes resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, and the client.

Key Responsibilities:
* Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs
* Perform QC of SDTM, ADaMs, and TFLs
* Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTMs and ADaMs
* Develop complex specifications for SDTMs and ADaM datasets
* Mentor less-experience programmers in department practices and processes

Required Skills and Qualifications:
* Bachelor's degree in mathematics, statistics, computing, life science, health science, or related subjects
* Typically 6 years of SAS programming experience in the CRO or Pharmaceutical industry
* Experience as lead statistical programmer on complex studies in clinical research
* Knowledge in all aspects of clinical trials from initial study set-up to study completion
* Broad knowledge of CDISC requirements related to SDTM and ADaM

Benefits:
* Comprehensive benefits package including Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO)
* Company bonus where applicable

Location:
Remote opportunities available in the U.S. or Canada regions
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