Principal Statistical Programmer

Posted 1 hour 23 minutes ago by IQVIA Argentina

Permanent
Full Time
Other
Dublin, Ireland
Job Description
Position

Principal Statistical Programmer - Full time - Home-based in Ireland.

Overview

The Principal Statistical Programmer will be responsible for the review of datasets in submission ready standard format (ADaM), tables, figures, listings and submission packages. The Senior Statistical Programmer will provide expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.

Responsibilities
  • Collaborate with study teams to design data structure and specifications for ad hoc and study deliverables including ADaM datasets, tables, figures, listings and analysis submission content.
  • Collaborate with study teams to ensure the quality and accuracy - thus submission readiness - of clinical data as required by authorities (SDTM, ADaM, tables, figures, listings, define.xml).
  • Lead and oversee requested efforts for pooled and exploratory analyses working closely with the Statistics TA lead and/or study statisticians as well as with the clinical programming team and their collection of legacy data.
  • Lead and oversee the in house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
  • Lead and oversee the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
  • Lead and oversee the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.
  • Work closely with clinical study teams to plan and execute activities to ensure project timelines are met with high quality deliverables.
  • Collaborate with CR&D staff regarding data analysis requests.
  • Perform additional statistical analyses including:
    • Support responses to regulatory agencies.
    • Generate integrated summary of safety and efficacy.
    • Support publications and presentations.
    • Support planning and reporting of clinical trials via exploratory analyses of available data.
Requirements
  • BSc in Computer Science, Mathematics, Statistics or related area with relevant experience.
  • At least 7 years of experience in clinical programming and/or statistical programming within the CRO/pharmaceutical environment using SAS Software.
  • In depth understanding of clinical programming and/or statistical programming processes and standards.
  • Extensive experience with statistical programming using SAS software, including development and use of SAS Macros; strong programming and problem solving skills.
  • Training and hands on experience of R Programming.
  • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
  • Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities.
  • Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
  • Experience working in cross functional, multicultural and international clinical trial teams.