Senior Biostatistician — Adaptive Trial Design
Königstein im Taunus, Germany (hybrid) · Remote EU considered
Own the statistical methodology behind Adaptrials — priors, estimands, operating characteristics — and guide sponsors through adaptive Phase II/III designs that pass reviewer scrutiny.
What you'll do
- Design and simulate adaptive and Bayesian clinical trials (adaptive randomization, group sequential, sample-size re-estimation).
- Lead prior-elicitation workshops with sponsor biometrics teams.
- Translate ICH E9(R1) estimands into analysis models and TLF specifications.
- Represent the statistical framework to regulators (FDA Type C / EOP2 / EMA).
What we look for
- MSc/PhD in biostatistics, statistics or equivalent; 5+ years in clinical trial statistics.
- Deep experience with Bayesian methods, Monte-Carlo simulation and adaptive designs.
- Fluent in R and/or Python; working knowledge of SAS for validation.
- Prior FDA or EMA interaction experience is a strong plus.
