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Principal Statistical Programmer

Katalyst HealthCares & Life Sciences

Company : Katalyst HealthCares & Life Sciences

Location : Boston, MA, 02109

Posted Date : 15 September 2025

Job Type : Other

Category : Software Development

Occupation : Programmer

Job Details

Responsibilities:
  • Play a pivotal role in leading statistical programming activities for multiple clinical trials, ensuring the timely and accurate delivery of analysis datasets, tables, listings, and figures.
  • Collaborate closely with cross-functional teams and clients to support the successful execution of clinical development programs.
  • Provide leadership and guidance to the statistical programming team, ensuring adherence to industry standards, best practices, and regulatory requirements.
  • Lead and coordinate statistical programming activities for assigned projects, including timeline management, resource allocation, and deliverable quality assurance.
  • Develop and validate analysis datasets, statistical tables, listings, and figures in accordance with study protocols, statistical analysis plans, and programming specifications.
  • Perform comprehensive quality control checks on programmed deliverables to ensure accuracy, consistency, and compliance with regulatory guidelines.
  • Collaborate effectively with cross-functional teams, including biostatistics, data management, and clinical operations, to address project requirements and resolve programming-related issues.
Requirements:
  • Bachelor's or master's degree in statistics, biostatistics, computer science, or related field.
  • Minimum of 5 years of experience in statistical programming within the pharmaceutical or biotechnology industry.
  • Proficiency in SAS programming language, including SAS/Base, SAS/STAT, SAS/MACRO, and SAS/GRAPH.
  • Strong understanding of clinical trial data structures, CDISC standards, and regulatory requirements (e.g., FDA, EMA, ICH).
  • Excellent leadership, project management, and communication skills.
  • Proven ability to work effectively in a dynamic, fast-paced environment and manage multiple priorities simultaneously.
  • Experience with programming in R or other statistical software packages is a plus.

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