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
LinHR is committed to providing accommodations for people with disabilities. If you require an accommodation, we will work with you to meet your needs. Accommodation will be provided in all parts of the hiring process as required under LinHR's Employment Accommodation Policy. Applicants need to make their needs known in advance. ​
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