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2 часа назад

Principal Biostatistician (Biostatistics)

Формат работы
remote (только Germany)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Germany
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Principal Biostatistician (Clinical Trials/SAS): Leading statistical strategy and delivering hands-on analysis support for late-phase clinical trials with an accent on Statistical Analysis Plans, advanced time-to-event and longitudinal methods, and estimand-based analyses. Focus on designing sample size calculations, guiding statistical programmers, and aligning cross-functional teams on scientifically rigorous and regulator-ready analytical decisions.

Location: Permanent homebased in Frankfurt, Hesse, Germany

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Serve as the primary statistical lead and Biostatistics point of contact for clinical trial teams.
  • Provide independent statistical guidance across the design, execution, and analysis of late-phase clinical studies.
  • Lead discussions on endpoints, analysis methods, estimands, risk mitigation, and regulatory expectations.
  • Author Statistical Analysis Plans and perform or oversee scientifically rigorous statistical analyses.
  • Conduct sample size calculations using SAS or R and justify design assumptions.
  • Direct statistical programming activities, review outputs, and collaborate with clinical, data management, medical writing, and programming partners.

Requirements

  • Advanced degree in Biostatistics, Statistics, or a related field; a PhD is preferred, while a Master's degree is accepted with significant experience.
  • Independent study statistician experience in Phase II/III clinical trials.
  • Hands-on experience with clinical outcomes studies, including cardiovascular events, symptomatic endpoints, and quality-of-life measures.
  • Expertise in complex statistical methods, including time-to-event analyses, MMRM, longitudinal models, and estimand-based approaches.
  • Proficiency in SAS; working knowledge of R is advantageous.
  • Ability to guide cross-functional teams and communicate statistical concepts clearly to non-statistical stakeholders.

Nice to have

  • Pharmaceutical industry experience; CRO experience is a plus.
  • Experience with regulatory submissions and interaction with health authorities.
  • Experience with R, CRM systems, or advanced analytical tools.

Culture & Benefits

  • Permanent homebased work arrangement.
  • Full-time employment.
  • Work within a global clinical research and healthcare intelligence organization.
  • Focus on integrity and truthful, complete application information.

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