Senior Analyst/Programmer

4 weeks ago


Somerset, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Overseeing SAS programming activities from varying aspects: programming, statistical and clinical
  • Create, manage, and maintain the SAS programming algorithm for the clinical study database and data analysis
  • Peer review the submission packages and contribute to the input of SAP and mock TFLs
  • Perform ad hoc analyses to support Phase I to IV clinical trials and medical publications
  • Maintain relationships with internal and external customers and vendors
  • Mentor up and coming junior programmers and analysts
  • Tracking projects against goals and submit status reports to project management
Requirements:
  • Bachelor's or advanced degree in statistics, biostatistics, computer science or related fields
  • 4 to 6 years' experience in the pharma/biotech industry
  • dvanced SAS programming skills (e.g, SAS SQL, SAS Macro, SAS/STAT, SAS/GRAPH, etc.) with clinical trial data
  • dvanced knowledge in industry standards, such as the ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines
  • Experience in handling and processing upstream data, e.g., EDC, eDT, SDTM, and in providing outputs to meet downstream requirements, e.g., ADaM, define.xml and TFLs


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