Senior Statistical Programmer

1 week ago

Warren, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • Working under the direction of the Team Lead / Project Manager, the senior statistical programmer conducts programming activities for a trial, early phase project, indication, or publication activities.
  • Lead at least one study team in terms of providing technical and domain-related guidance.
  • May required to lead and manage a team of 2-4 members.
  • Experience of working on Oncology TA is mandatory.
  • Ability to work on data migration from legacy datasets to standards such as CDISC or any other client-specific standard.
  • Read and understand the program specifications document.
  • Prepare SAS analysis datasets, tables, listings, and figures as per specifications.
  • Create programs to create graphs and tables that are required in CSRs, safety reports, efficacy reports, etc. ensuring on-time quality delivery.
  • Validate and transform datasets as per client assignment specifications.
  • Validate tables, listings, and figures as per client assignment specifications.
  • Coordinate with the client and US team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
  • Contribute in the organization's recruitment process by identifying needs and required skill sets of resources and conducting interviews to hire appropriate resources.
  • Perform all the above tasks using standard operating procedures (SOPs) as defined in the Quality Management System or the respective client(s) as applicable.
Requirements:
  • BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 5 years of SAS programming experience with clinical trial data.
  • Well-conversed with regulatory requirements and drug development process.
  • Good understanding of the Clinical trial domain and good SAS programming skills.
  • Ability to work independently.

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