Senior/Principal Statistical Programmer

2 weeks ago


New York, New York, United States Katalyst Healthcares & Life Sciences Full time

RESPONSIBILITIES:

  • Following the Study Data Tabulation Model (SDTM) Implementation Guide, drafting specifications for SDTM datasets
  • Based on statistical analysis plans and the Analysis Data Model (ADaM), writing specifications for analysis datasets
  • Developing algorithms and creating datasets as per specifications
  • Generating data listings, summary tables, and graphs using SAS software
  • Independently reviewing data listings, summary tables, and graphs
  • Handling import and export of SAS data
  • Supporting the data management team in conducting data edit checks
  • Ensuring work aligns with GCP, ICH, 21 CFR part 11, internal SOPs, training, and global regulatory requirements
  • Contributing to project solutions and their adaptation for the Biostatistics unit
  • Collaborating with the project statistician and providing guidance to fellow team programmers
  • Proficiency in Pooled analysis, knowledge of regulatory agencies' demands, and e-submission familiarity

REQUIREMENTS:

  • A minimum of 10+ years of statistical programming expertise in the life science sector with a relevant bachelor's degree
  • Recent NDA submissions exposure is mandatory
  • Experience in ISS/Client safety & efficacy is vital
  • Skills in creating and utilizing Pinnacle 21 and specifications
  • Preferably SAS Certified Base and/or Advanced Programmer
  • Demonstrated competence in SAS programming encompassing base SAS, SAS/Stat, SAS/Graph, macros, ODS
  • Familiarity with SDTM and ADaM data standards in the industry
  • Effective communication abilities and keen attention to detail
  • Proven capacity to manage multiple tasks
  • Capable of advocating own concepts and convincing others by adeptly consolidating, evaluating, and presenting relevant information


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