As Associate Director Biostatistics, you will provide senior statistical leadership across clinical and translational programs. This is a hands-on, high-autonomy role with strong matrix leadership: you will shape quantitative strategy, guide study design and analysis, oversee complex computational work, and help teams make clear, evidence-based decisions.
You will work closely with Clinical Development, Clinical Operations, Data Management, Biomarkers, Regulatory, external partners, CROs, and senior stakeholders. The role requires critical thinking, scientific maturity, strong communication, and the ability to operate pragmatically in a fast-moving biotech environment.
What You Will Do
- Serve as biostatistical lead for clinical and translational projects, including protocol design, endpoints, estimands, sample size, SAPs, TLFs, interim/adaptive decisions, reporting, and regulatory responses;
- Develop and defend quantitative strategies using frequentist and Bayesian methods, simulation, leveraging external evidence, sensitivity analyses, and decision-focused interpretation;
- Plan, oversee, monitor, QC, and document demanding computational work, ensuring reproducibility, traceability, and fit-for-purpose quality;
- Contribute to clinical development strategy by translating biological, clinical, regulatory, and operational questions into robust statistical plans;
- Author and review statistical sections of protocols, synopses, briefing books, CSRs, regulatory documents, internal decision memos, and presentations;
- Oversee CROs, consultants, programmers, and analytical vendors to ensure timelines, quality, documentation, and audit readiness;
- Support GCP-aware ways of working and contribute to statistical quality systems, clinical data infrastructure, and good documentation practice;
- Identify statistical, data, interpretability, and operational risks early, and propose pragmatic mitigation options;
- Mentor colleagues in a matrix setting and promote quality, scientific challenge, and clear communication.
We expect our Associate Director Biostatistics to have
- PhD or MSc in biostatistics, statistics, mathematics, data science, epidemiology, or a related quantitative discipline;
- At least 5 years of relevant experience (3+ if PhD.) in biotech, pharma, CRO, academic clinical research, or a comparable setting;
- Experience leading statistical work for clinical studies, ideally including rare disease, small populations, translational medicine, precision medicine, or innovative trial designs;
- Strong command of R is required. Python is a clear plus. SAS is useful but not mandatory;
- Good command of Bayesian models, Bayesian thinking, adaptive or innovative designs, and simulation-based planning;
- Ability to design and critically review complex analyses, not just execute them;
- Familiarity with cloud or controlled computation environments, reproducible workflows, version control, and data-science techniques;
- Knowledge of GCP and experience with regulatory interactions are strong pluses;
- Strong written and verbal communication in English;
- High integrity, quality mindset, pragmatic problem-solving, and the confidence to challenge assumptions constructively.
Skills and competencies that are required for making the difference
We are looking for someone who combines statistical depth with strategic judgement. You are comfortable working independently, but you also know how to bring people with you. You can move between hands-on analysis, study-level statistical leadership, and senior stakeholder discussion. You communicate proactively, clearly, respectfully, and fearlessly.
If this role sounds exciting but you do not meet every criterion, we would still like to hear from you. Some gaps can be closed by doing the work; critical thinking, ownership, quality, and willingness to learn are essential.
