Senior Clinical Biostatistician (m/f/d)

Freseniusglobal (Fk Careers De); Bad Homburg vor der Höhe; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

Fresenius is seeking a senior biostatistician to advance methodological work across preclinical and clinical studies within an international team. The role focuses on study design, endpoint choice, and regulatory-grade analyses rather than programming.

You will shape strategies, review SAPs, guide CROs, translate outputs for cross-functional stakeholders, and contribute to clinical study reports. Fluency in English and SAS expertise are essential; R is a plus.

Qualificações

• University degree in biostatistics, statistics, mathematics, or a comparable quantitative discipline.
• At least 5 years in pharma/biotech/CRO with focus on clinical research and biostatistical methodology.
• Experience in clinical study design, SAPs, analyses, and interpretation of results.
• Understanding of regulatory expectations and CDISC ADaM for submissions.
• Excellent SAS knowledge; R is an advantage.
• Knowledge of Real-World Evidence methodologies; PK/PD or adaptive designs are a plus.
• Strong communication to explain concepts to non-statistical stakeholders.
• Open, proactive mindset and cross-disciplinary collaboration.
• Fluency in English, both written and spoken.

Responsabilidades

• Shape and review biostatistical strategies for studies across phases I–IV.
• Act as statistical expert for study design, endpoints, sample size, and interpretation.
• Develop, review, and challenge SAPs and methodological concepts.
• Oversee CROs and external partners for quality and timelines.
• Translate analyses into clear recommendations for cross-functional stakeholders.
• Contribute to clinical study reports and integrated summaries.
• Provide input to CRFs, edit checks, data validation plans, and outputs.
• Explore AI-supported approaches to improve efficiency and decision-making.

Conhecimentos

Biostatistics

Clinical study design

Statistical methods

Regulatory understanding

Communication skills

Open mindset

English fluency

Formação académica

University degree in biostatistics / statistics / mathematics

Ferramentas

SAS

R

Descrição da oferta de emprego

At Fresenius, we are committed to advancing healthcare through innovation, technology, and patient-centric solutions. In this role, you will join an experienced international team and contribute your biostatistical expertise to clinical and pre-clinical studies supported by Fresenius Kabi.

We are looking for someone who enjoys working collaboratively, brings a proactive and open mindset, and is motivated to further develop biostatistical approaches in a practical, solution-oriented way. The focus of this position is on biostatistical methodology, study design, interpretation, and cross-functional guidance rather than on statistical programming as a primary responsibility.

Your Responsibilities

• Shape and review biostatistical strategies for pre-clinical and clinical studies across phases I–IV, including non-interventional and Real-World Evidence studies.

• Act as a statistical expert and sparring partner for clinical development teams, contributing to study design, choice of endpoint, sample size calculations, protocol discussions, and interpretation of results.

• Develop, review, and challenge Statistical Analysis Plans and methodological concepts to ensure scientifically sound and regulatory-relevant approaches.

• Oversee and guide CROs and external partners to ensure high-quality biostatistical deliverables, clear timelines, and alignment with study objectives.

• Translate statistical analyses and key outputs into clear recommendations for clinical, regulatory, medical writing, data management, and other cross-functional stakeholders.

• Contribute to clinical study reports, integrated summaries, and submission-related documents from a biostatistical perspective.

• Provide biostatistical input to CRFs, edit check specifications, data validation plans, and standards for statistical outputs.

• Explore innovative and AI-supported approaches that can improve efficiency, quality, and practical decision-making in clinical studies.

Your Qualifications

• University degree in biostatistics, statistics, mathematics, or a comparable quantitative discipline.

• At least 5 years of relevant experience in the pharmaceutical, biotechnology, or CRO environment, with a strong focus on clinical research and biostatistical methodology.

• Solid experience in clinical study design, Statistical Analysis Plans, statistical analyses, and interpretation of clinical study results.

• Strong understanding of regulatory expectations and CDISC requirements for submissions, particularly ADaM.

• Excellent SAS knowledge is required; experience with R is an advantage.

• Knowledge of Real-World Evidence methodology is highly welcome; experience with PK/PD studies, bioequivalence studies, or adaptive designs is a plus.

• Strong communication skills and the ability to explain statistical concepts, methodological choices, and the impact of decisions to non-statistical stakeholders.

• Open, curious, and proactive mindset with the motivation to bring in new ideas, explore practical solutions, and collaborate across disciplines.

• Fluency in English, both written and spoken.

Ready to make an impact?

If you want to use your biostatistical expertise to shape clinical development decisions, bring fresh perspectives into an international team, and contribute to healthcare solutions that matter, we look forward to receiving your application.