Metronomia Clinical Research GmbH - Principal Statistician
Summary
METRONOMIA stands for quality, competence, continuity, and unconditional customer orientation in terms of statistical services and data management in clinical research. As a growth‑oriented medium‑sized company with around 155 employees, we operate internationally. Our customers appreciate the competence and commitment of our employees and we value our employees as the basis of the company’s success. Join a motivated and friendly team and help shape Metronomia as a Principal Statistician.
Key responsibilities
* Project Management for our biostatistical services, provide technical supervision and lead project teams in all biostatistical activities of clinical trials.
* You act as the primary point of contact for our project clients.
* You manage the budgets of your projects, including preparation and review of cost proposals and performance reports.
* You will attend bid defense meetings and present biostatistical services including statistical programming and operational bids.
* You will represent Biometrics in governance meetings, regulatory inspections and client audits.
Your profile
* University degree in statistics, mathematics, mathematical biometrics or a comparable qualification.
* Several years of professional experience (5 - 7 years) in the statistical evaluation of clinical trials in a CRO or the pharmaceutical industry and already held project responsibility.
* Expert knowledge of clinical trial design, including adaptive and innovative designs, interim analysis planning, multiplicity control strategies, and the estimands framework.
* Deep proficiency in statistical modeling and inference, including linear models, mixed‑effects models, survival analysis, and longitudinal data methods.
* Strong familiarity with relevant regulatory guidance and industry standards (e.g., ICH guidelines, FDA/EMA guidance) and their practical application in trial design, analysis, and reporting.
* Study planning and decision support, including endpoint/estimand strategy, sample size and power calculations, and the use of simulation to assess operating characteristics.
* Advanced proficiency in SAS for analysis and reporting; ability to oversee programming standards and ensure reproducible, validated outputs.
* Oversight of statistical deliverables for clinical trials, including authorship and critical review of Statistical Analysis Plans and shells, PD definitions, data review meeting, TFLs.
* Outstanding communication and stakeholder management skills, including project team of statisticians and programmers, clients, etc.
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