Sr. Statistical Programmer

2 weeks ago

Gwynedd, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Utilize SAS to generate and validate tables, listings, and figures (TLF) based on SAP.
  • Use major statistical programming language to perform data analysis for various needs.
  • Provide statistical analysis support for post approval studies.
  • Evaluate and ensure CDISC compliance of study tabulation and analysis data files.
  • Write specifications and statistical programs to generate analysis datasets and outputs.
  • Perform data analysis tasks with minimal supervision.
  • Provide programming support for data management.
  • Develop statistical toolbox for advanced data modelling, tabulation, and visualization.
  • Participate in reviewing and validating data analysis results.
Requirements:
  • Strong SAS programing skill in producing various types of outputs such as TLFs and datasets with minimum of 3 years of experiences.
  • Extensive statistical programming experience in producing deliverables either on scheduled or ad hoc basis.
  • BS degree in Statistics, Mathematics, Computer Science, or related field, MS in Statistics or Biostatistics is preferred.
  • 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.
  • ttention to detail and able to adapt to a fast-paced environment.
  • bility to work both independently and in a cross-functional team.
  • Excellent communication skills
  • Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance