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IQVIA
last mo.

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

Frankfurt am Main
Full-timeWith Home OfficeSenior

Description

In this role, you will engage in a variety of tasks, including reviewing datasets and ensuring their submission readiness, leading complex analyses, and collaborating with study teams. Your expertise will help shape the quality and efficiency of clinical data reporting.

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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

Education

Bachelor's degree

Work Experience

5 years

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

Tools & Technologies

SAS

Languages

EnglishBusiness Fluent

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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