Associate Director Biostatistics

ProQR Therapeutics is a NASDAQ-listed biotechnology company headquartered in Leiden, the Netherlands with an office in and Cambridge, Massachusetts, USA.
At ProQR, we are on a mission to edit RNA, treat disease and change lives. A team of 180+ enthusiastic ProQRians from all walks of life and more than 30 different nationalities is committed to pioneering transformative RNA therapies to make a difference in the lives of the communities we serve.

Our proprietary Axiomer™ RNA editing technology platform enables the editing of specific single nucleotides in RNA using the cells own editing machinery. Axiomer RNA editing technology harnesses ADAR (Adenosine Deaminase Acting on RNA), a protein which is present in all human cells, to repair G-to-A mutations, modulate protein, and enable protective mutation functions. Axiomer could potentially yield a new class of innovative medicines and treat currently untreatable diseases. By harnessing the power of RNA editing, we aim to create a world where genetics inform your health - but never limit it.

Our Development / Clinical Quantitative Science department is currently looking for an Associate Director Biostatistics (Full-time) to join our team.

Location: Leiden, the Netherlands (on-site).

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.

ProQR as an employer

As an employer, we value a diverse workforce in which people are encouraged to develop themselves both personally and professionally. We believe that when people are happy, energized and supported by an environment in which they can thrive, they can achieve extraordinary things.

We are committed to ensuring that no employee, candidate, or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and contributions in all forms are recognized and valued.

We offer an exciting and innovative working environment in a very committed organization, with the following benefits:

• 8% holiday allowance

• 30 vacation days

• An annual performance bonus

• Stock options

• A premium-free pension plan

• A commuting allowance

• A subsidized staff restaurant

• Unlimited (un)healthy snacks and drinks

• Employee events (boot camp, Coffee and Collaboration Café and other social events)

We are looking for people who are inspired by our mission to edit RNA, treat disease and change lives. Are you up for the challenge?

Submit your application via the Apply button below. Please contact Silvia Catellani via [email protected] if you have any questions.

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