LinHR's client - a clinical development CRO dedicated to providing high-quality services including regulatory affairs, medical affairs, clinical operation, data management, statistical analysis, programming, and biological sample analysis. They are the most trusted and fastest-growing clinical trial service provider/partner for both domestic and overseas sponsors.
They are looking for a Senior/Principal Statistical Programmer​ (Full Time) in Piscataway, NJ, United States.

Responsibilities  

  • Provide on-time delivery with high-quality service 
  • Independently develop and/or QC SDTM and ADaM programming specifications, following the CDISC standards, and other programming supporting documents 
  • Independently develop and/or validate SDTM, analysis datasets, tables, figures and listings 
  • Generate Define-XML package for FDA submission 
  • Lead a statistical programming team to successful completion of a project within given timelines and budget 
  • Independently interact with Sponsors with regard to statistical programming issues 
  • Create standard macros and applications to improve the efficiency of the department and Proactively participate in and/or lead process/quality improvement initiatives 
  • Ensure all activities in accordance with internal and external quality standards, SOPs/working instructions (WIs), ICH-GCP and/or any other applicable local and international regulations, guidelines and industry standards 

Requirements​

  • Bachelor degree or above in biostatistics, statistics, mathematics, computer science or relevant scientific disciplines 
  • >3 years SAS programming experience in clinical trial industry 
  • Strong oral and written communication skills, with ability to communicate effectively internally and with clients. 
  • Work experience in SAS Base and understand SAS/Macros, SAS/Graph, SAS/Stat and reporting process Work experience in CDISC SDTM/ADaM standards 
  • Familiar with ICH-GCP and any other applicable local and international regulations, guidelines and industry standards 
  • Timeline adherence, reliability, efficiency, attention to details, quality driven 
  • Initiative, problem solving and take extra responsibility 
  • Good project management skills 
  • Good team collaboration