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Principal Statistical Programmers

Roles & Responsibilities

  • 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
  • Experience working in Oncology Therapeutic Area (TA) is mandatory
  • Well-versed with regulatory requirements and the drug development process
  • Ability to work independently

Requirements:

  • Lead at least one study team, providing technical and domain-related guidance; may manage a team of 2-4 members
  • Prepare SAS analysis datasets, tables, listings, and figures per specifications after reviewing the program specifications; develop programs to generate graphs and tables required in CSRs, safety reports, and efficacy reports; ensure on-time quality delivery
  • Validate and transform datasets per client specifications; validate tables, listings, and figures per client specifications; coordinate with the client and US team for clarity of specifications, data issues, outliers, reviews, and schedules
  • Contribute to recruitment by identifying resource needs and required skill sets and conducting interviews to hire appropriate resources; follow SOPs in the Quality Management System or client requirements

Job description

We are looking for experience Statistical Programmers to work with one of our clients.

Job 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.

Benefits

  • HMO with 1 free dependent upon hire
  • Life Insurance
  • 10% Night Differential
  • 20 PTO credits annually
  • VL and SL cash conversion
  • Annual Performance-Based Merit Increases and Employee Recognition
  • Great Company Culture
  • Career Growth and Learnings
  • Night Shift
  • Work from Home

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