Senior Statistical Programmer

4 weeks ago


Jersey City, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Implement CSDIC standards and guidelines for data management and analysis in clinical trials.
  • Transform and map raw clinical trial data to SDTM and ADaM datasets.
  • Collaborate with clinical teams to ensure data quality and accuracy, with a focus on oncology products.
  • Generate analysis-ready datasets for statistical analysis and reporting.
  • Conduct statistical analyses to evaluate the safety and efficacy of oncology therapies.
  • Prepare tables, listings, and figures (TLFs) for clinical study reports.
  • Ensure compliance with regulatory requirements for data submissions.
  • Contribute to the development of data quality control processes.
  • Participate in data visualization and data cleaning tasks as needed.
  • Stay updated with industry standards, best practices, and emerging trends in SAS programming for clinical trials.
Requirements:
  • Bachelor's degree in a related field from a United States college or university (master's degree preferred).
  • 5+ years of experience as a SAS Statistical Programmer in the pharmaceutical, biotechnology, or clinical research industry.
  • Deep understanding of CSDIC standards, SDTM, and ADaM.
  • Experience working on oncology products and clinical trials.
  • Proficiency in SAS programming, including data transformation and statistical analysis.
  • Familiarity with regulatory submissions and compliance.
  • Strong problem-solving and analytical skills.
  • Excellent communication and teamwork abilities.
  • Detail-oriented with a commitment to data quality and accuracy.


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