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IQIQVIA

Senior Statistical Programmer - FSP(m/w/x)

Frankfurt am Main
Full-timeWith Home OfficeSenior

Leading pooled analyses and creating submission-ready ADaM datasets for regulatory submissions at a global healthcare data science firm. 5+ years of clinical programming experience with extensive SAS expertise required. Home-based remote work.

Requirements

  • BSc in Computer Science, Mathematics, Statistics or related area
  • At least 5 years of experience in clinical programming or statistical programming
  • In-depth understanding of clinical programming and statistical programming processes
  • In-depth understanding of regulatory requirements relevant to statistical programming
  • Extensive experience with statistical programming using SAS software
  • Strong programming and problem-solving skills
  • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
  • Proven experience in leading programming activities for clinical studies
  • Ability to work effectively independently or in a team setting
  • Experience in cross-functional, multicultural and international clinical trial teams

Tasks

  • Review datasets in submission-ready standard format (ADaM)
  • Create tables, figures, listings, and submission packages
  • Collaborate with study teams to design data structures and specifications
  • Ensure quality and accuracy of clinical data for submission readiness
  • Lead pooled and exploratory analyses with Statistics TA lead and study statisticians
  • Oversee in-house specification and delivery of ISS and ISE datasets
  • Design and implement complex SAS programs for clinical trial data analysis
  • Develop global tools to enhance efficiency in the Statistical Programming group
  • Plan and execute activities with clinical study teams to meet project timelines
  • Collaborate with CR&D staff on data analysis requests
  • Perform additional statistical analyses to support regulatory agency responses
  • Generate integrated summaries of safety and efficacy
  • Support publications and presentations
  • Conduct exploratory analyses for planning and reporting of clinical trials

Work Experience

  • 5 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • SAS

Benefits

Flexible Working

  • Home-based remote work opportunities

Family Support

  • Great work/life balance

Informal Culture

  • Collaborative team environment

Job Security

  • Job stability

Career Advancement

  • Career advancement opportunities
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