Clinical Study and Biostatistician Expert

Extensive experience throughout the clinical certification cycle, I have strategically led clinical teams in study design, execution, statistical data analysis, and report submissions. Focusing now on biostatistical strategy and statistical analysis.

• Data Science
• DiGA
• DiPA
• Drug Discovery
• DTx (Digital Therapeutics)
• Gute Klinische Praxis1 J.
• Klinische Forschung1 J.
• Python1 J.
• Statistiken

I hold a PhD in Computational Neuroscience with a focus on research poised for commercialization. This academic pursuit provided me with extensive hands-on experience in clinical trial execution and the certification process. I have led multidisciplinary teams in clinical and data science, utilizing advanced algorithms for product development and conducting rigorous statistical analyses essential for clinical study validations. My experience extends to ensuring quality assurance and compliance with regulatory requirements, integral for medical product certification across all classes. My goal is to leverage this comprehensive expertise to deliver precise, validated biostatistical strategies and statistical data analysis according to regulatory standards to clients.

Advanced Biostatistical Analysis:
Proficient in designing, executing, and interpreting statistical analyses using R, tailored to meet the stringent requirements of clinical study design and execution, ensuring robust, compliant, and scientifically sound outcomes.

Regulatory Compliance and Clinical Certification:
In-depth understanding of Medical Device Regulation (MDR), including specific standards such as ISO 13485 for quality management and ISO 14155 for clinical trial conduct. Expert in ensuring studies are compliant with EU regulations and ISO standards.

Data Integrity and Quality Assurance:
Skilled in managing data quality from collection through analysis, supported by strong knowledge of ISO 27001 and proficiency in R for statistical computing.

Medical Device and Digital Health:
Experienced in leading projects in digital health applications (DiGA and DiPA) in Germany, managing collaborations with CROs and direct interactions with regulatory bodies such as BfArM.

Medical Writing and Statistical Programming:
Adept in using R for statistical programming, complemented by strong capabilities in medical writing for study protocols, reports, and regulatory submissions.