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Katalyst HealthCares & Life Sciences
Principal SAS ProgrammerKatalyst HealthCares & Life Sciences • Minneapolis, MN
Principal SAS Programmer

Principal SAS Programmer

Katalyst HealthCares & Life Sciences • Minneapolis, MN
30+ days ago
Job type
  • Full-time
Job description

Responsibilities:
  • The Principal SAS Programmer will be responsible for statistical programming for the client's clinical studies.
  • In this role, you will develop and validate SAS programs for data presentation, analyses, and provide programming support to project team members.
  • Our Ideal candidate will have a strong work ethic capable of thriving in a high growth, fast paced and intellectual environment.
  • Serves as lead programmer for assigned projects to provide statistical and programming support in one or more Phase I-III clinical studies.
  • Design and perform quality checks on analysis datasets, tables, listings, figures (TFL), and written reports to support clinical trial results using SAS.
  • Create and review annotated CRF to STDM datasets.
  • Produce and maintain technical programming specification documents.
  • Lead and actively participate in client and project review meetings.
  • Communicate with clients regarding study protocol or statistical analysis issues.
  • Validate statistical deliverables and ensure that appropriate statistical methods are utilized.
  • Ensure adherence to industry standards and regulatory requirements.
  • Facilitate the development and application of adequate statistical methods in clinical research.
Requirements:
  • PhD or MS degree in Statistics, Biostatistics or related field.
  • + years of relevant work experience in CRO, biotech, pharmaceutical, or life sciences industry.
  • Familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines (FDA/EMA, ICH/GCP).
  • Experience with NDA/BLA submission activities.
  • Experience in statistical programs such as Statistical Analysis System (SAS), CDISC and SDTM.
  • Maintain awareness of industry standards, regulatory requirements, departmental guidelines, and Standard Operating Procedures (SOP's).
  • Excellent organizational skills, time management, ability to prioritize workload, and meet deadlines.
  • Excellent communication and interpersonal skills to effectively interact with others.

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Principal SAS Programmer • Minneapolis, MN

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