Associate Director Biostatistics

ProQR Therapeutics N.V.; Leiden; On-site; EUR 110,000 - 160,000; Full time

Benefits offered by this job

Annual performance bonus

Stock options

Pension plan

Commuting allowance

Snacks and drinks

Employee events

Job summary

ProQR Therapeutics N.V. in Leiden, the Netherlands, seeks an Associate Director Biostatistics to provide senior statistical leadership across clinical and translational programs.

This hands-on, high-autonomy role shapes quantitative strategy, study design, and analysis, while guiding teams and external partners to data-driven decisions. You will collaborate with Clinical Development, Data Management, Regulatory, and CROs, driving robust statistical plans and ensuring high-quality documentation

Qualifications

• PhD or MSc in biostatistics, statistics, mathematics, data science, epidemiology, or related field.
• 5+ years in biotech/pharma/CRO or academic clinical research (3+ if PhD).
• Experience leading statistical work for clinical studies and designs.
• Proficiency in R; Python a plus; SAS useful but not mandatory.
• Knowledge of GCP and regulatory interactions is a strong plus.
• Strong written and verbal English communication.
• Familiarity with cloud environments, reproducible workflows, and version control.

Responsibilities

• Serve as biostatistical lead for clinical and translational projects, incl. design, endpoints, estimands, sample size, SAPs, TLFs.
• Develop and defend quantitative strategies using frequentist and Bayesian methods and simulations.
• Plan and oversee demanding computational work with reproducibility and audit readiness.
• Author and review statistical sections of protocols, synopses, CSRs, and regulatory documents.
• Oversee CROs, consultants, and vendors to ensure timelines and quality.
• Support GCP-aligned workflows and clinical data infrastructure.
• Identify statistical and operational risks early and propose mitigations.
• Mentor colleagues in matrix settings and promote quality and communication.

Skills

R

Python

SAS

GCP knowledge

English communication

Biostatistics leadership

Education

PhD or MSc in biostatistics or related

Tools

R

Python

SAS

Job description

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).

The Role

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.

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:

• An annual performance bonus
• Stock options
• A premium-free pension plan
• A commuting allowance
• 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?

We are an innovative biotech company headquartered in Leiden, the Netherlands. We focus on the development of life-changing RNA therapies for severe rare and common diseases. Are you up for a challenge?

ProQR was founded by Daniel de Boer with a mission to help people living with rare genetic diseases. This remains the sole focus of our company today.

Our passion lies in discovering the latest RNA technologies and translating them to life-changing treatments for people with severe rare and common diseases.