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IQIQVIA

Principal Biostatistician(m/w/x)

Frankfurt am Main
Vollzeitmit HomeofficeSenior
Data Science

Leading statistical strategy for Clinical Trial Teams (CTT) at a global clinical research provider. Independent study statistician experience in late-phase clinical trials, pharmaceutical industry experience strongly preferred. Diverse global clinical trial projects.

Anforderungen

  • Advanced degree in Biostatistics, Statistics, or related field (PhD preferred; Master’s with significant experience)
  • Proven independent study statistician experience in late-phase clinical trials
  • Pharmaceutical industry experience (strongly preferred); CRO experience (plus)
  • Hands-on expertise with clinical outcomes studies
  • Ability to implement complex statistical methods and guide analytical decision-making
  • Proficiency in SAS; working knowledge of R (advantageous)
  • Regulatory submissions and health authority interaction experience (plus)

Aufgaben

  • Lead as the primary statistician on the CTT.
  • Represent Biostatistics on the CTT.
  • Work independently to support clinical teams.
  • Provide proactive statistical guidance.
  • Lead statistical strategy discussions.
  • Define study endpoints and analysis methods.
  • Address risk mitigation and regulatory expectations.
  • Independently author Statistical Analysis Plans (SAPs).
  • Conduct complex time-to-event analyses.
  • Apply MMRM and longitudinal models.
  • Utilize estimand-aligned statistical methods.
  • Perform and oversee statistical analyses.
  • Conduct sample size calculations using SAS or R.
  • Justify design assumptions to clinical leadership.
  • Collaborate with statistical programmers.
  • Provide clear direction to programmers.
  • Review statistical programming outputs.
  • Ensure SAP and programming alignment.
  • Perform hands-on SAS programming for clinical datasets.
  • Actively participate in CTT meetings.
  • Drive alignment across cross-functional teams.
  • Communicate proactively with team members.
  • Anticipate team needs and address issues.
  • Ensure clarity on statistical approaches.
  • Explain statistical concepts to non-statistical stakeholders.

Berufserfahrung

  • ca. 4 - 6 Jahre

Ausbildung

  • Master-Abschluss

Sprachen

  • Englischverhandlungssicher

Tools & Technologien

  • SAS
  • R
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