Clinical SAS programmer

2 weeks ago

Parsippany, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Generate and validate tables, listings, and figures (TLF) based on statistical analysis plan (SAP)
  • Work with statistician to provide statistical analysis support for publication effort
  • Use major statistical programming language to perform data analysis for various needs
  • Provide statistical analysis support for post approval studies
  • Write specifications and statistical programs to generate analysis datasets and outputs data analysis tasks with minimal supervision
  • Work with statisticians to develop statistical toolbox for advanced data modelling, tabulation, and visualization
Requirements:
  • At 3+ years' experience in medical device, pharmaceutical, biotech and/or CRO industries
  • Strong SAS programming skill in producing various types of outputs such as TLFs and datasets
  • Extensive statistical programming experience in producing deliverables either on scheduled or adhoc basis
  • Experience with producing outputs submitted to the FDA and other regulatory agencies
  • Excellent organizational skill to prioritize multiple tasks and goals to ensure timely completion
  • Attention to detail and able to adapt to a fast-paced environment
  • Ability to work both independently and in a cross-functional team
  • Excellent communication skills
  • Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance
  • Adequate knowledge in clinical trial research methodology, ICH, GCP and regulations
  • Experiences in medical device and cardiovascular disease is desirable, but not required

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