Clinical SAS Programmer Job at Katalyst Healthcares and Life Sciences, Houston, TX

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  • Katalyst Healthcares and Life Sciences
  • Houston, TX

Job Description

Responsibilities:
  • Participate in the execution of global studies for regulatory submissions, reimbursement, and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.
  • Statistical programming of deliverables for regulatory submissions, including detailed and systematic specification of study variables, outputs, and response to regulatory questions.
  • Develop SAS macros, templates and utilities for data reporting and visualization.
  • Write and validate SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports and analysis datasets.
  • Proactively seek out and follow best practices in programming documentation.
  • Lead the statistical programming thinking, analysis, and reporting to relevant groups in product and study teams. Other duties as assigned.
Requirements:
  • B.S. degree in statistics, computer science, mathematics or related areas and 5+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry or a master's degree in Biostatistics or Epidemiology and 3+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry
  • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
  • Proficiency in SAS includes the use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data, and survival analysis required. SAS certification preferred.
  • Experience with analysis of medical device trials for PMA or 510(k) preferred
  • Experience with implementing CDISC standards preferred.
  • bility to work effectively on cross-functional teams.
  • Effective communication skills with all levels of management and organizations
  • Operates both as a team and independently, with adaptability to changing requirements.
Katalyst Healthcares and Life Sciences

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