2 часа назад
Principal Biostatistician (Biostatistics)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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