Dr. Adjmal Sarwary

Clinical Trial and Biostatistics Expert

Highly skilled data manager and biostatistician with extensive experience in designing and analyzing clinical trials and research projects. Adept at applying advanced statistical methodologies to translate complex data into understandable results. Proven track record in regulatory compliance and successful collaboration with regulatory bodies such as BfArM.

Demonstrated ability to work in cross-functional teams, manage large-scale projects.

My Work

My focus is helping clients with biostatistics and clinical trial designs across all phases. It’s crucial to get this right from the start to make sure the study design, data acquisition and analysis are all according to clinical trial standards. 

Among many things, this involves:

  • Sample size estimation
  • Development and assessment of Statistical Analysis Plans (SAPs)
  • Data management (cleaning, preparation, integrity checks)
  • Statistical Analysis & Modeling (descriptive & inferential)
  • Explain complex statistical concepts to non-statistical audiences in a clear and understandable manner.
Regulatory Experience
  • ICH
  • GCP
  • MDR
  • ISO 13485
  • ISO 27001
  • ISO 14155
Tools & Software
  • R (for statistical analysis)
  • Python
  • Matlab
  • Microsoft Office Suite

References

Work Experience

Freelance Clinical Trial and Biostatistician

I help clients with clinical trial setup, study design, ethical approval, regulatory body interactions (e.g., BfArM), clinical data management, biostatistical data analysis, and report generation. 

Most recent project

Role: Leading Clinical Trial Design and Biostatistician
Project: Development of a digital therapeutic with the aim of getting it listed for reimbursement in the new digital nursing application scheme (DiPA) in Germany.

  • Develop study design in accordance with the regulatory requirements – ISO 14155

  • Biostatistical analysis plan development and statistical analysis execution

  • Successfully apply for ethical approval and collaborate with university research partners

  • Led CRO management and achieved early strategy approval from the BfArM

Head of Clinical Research and Development at Lindera

Lindera is a medical device company developing app-based software to aid caregivers in fall prevention of the elderly. The software uses the latest AI and computer vision developments and requires clinical evidence
and adherence to strict medical device guidelines.

  • Successfully leading the clinical research and data science team by implementing and standardizing collaboration processes and tools

  • Strong focus on team member development on an individual basis, for example development of senior data science team member to head position and establishment of personal career and skill development plans for my and data science team members

  • Effective allocation of resources and budget planning by freeing company resources through standardizing and then automating other department’s processes

  • Development and training of standard operating procedures

  • Successfully collecting data for algorithmic validation by establishing partnerships with research institutions and establishing data analysis pipelines

  • Established processes for continuous verification and validation of algorithms

  • Successfully passed the in-person TÜV audit for the ISO 13485, by being part of the audit team being responsible for clinical evidence and algorithmic quality development

  • Completed first phase of creating a new product and its implementation by close communication with customers and translating academic research into algorithmic solutions

  • Received a three-year R&D grant from the BMBF to continue algorithmic development for the Data Science Team

  • Developed a unifying code library that can be modularly used by different teams

CEO & Founder of tech startup MindTrace

MindTrace is a technology startup using AI and Neuroscience to extract behavioral information at scale by using just a webcam. This technology is used to provide user experience testing services to market research and design development companies.

  • Created software to use a webcam as an eye tracker, emotion tracker, and heart rate tracker.

  • Implemented and developed data analysis techniques with machine learning and computer vision. The aim was to extract facial movement parameters and infer gaze, emotion, and arousal.

  • Led user experience and software development teams for product design and implementation.

  • Multi-faceted stakeholder management bridging investors, clients, and academics

Postdoctoral Researcher

I was awarded a high risk/high gain grant to investigate corticospinal signals in fast and slow motor adaptation processes. This research took place at the Donders Institute for Brain, Cognition, and Behaviour. The resulting paper can be found here.

PhD – Cognitive Neuroscience

My interdisciplinary PhD took place at the Radboud University Medical Centre and the Donders Institute for Brain, Cognition, and Behaviour.

  • Doctoral Thesis: Mechanisms of interference between motor memories
  • Designed and executed several research projects to final publications.
  • Focused on the analysis of reaching movements to assess the adaptation process and use statistical models to understand the underlying mechanisms.

Grants

BMBF Research Grant

Stimulating the intersection of Research & Business

STW – Take Off Grant

Valorization of fundamental research to product

Research Feasibility Grant

Funding for high risk – high gain neuroscience research

Education

Cognitive Neuroscience Master (MSc)

Radboud University Nijmegen, The Netherlands

University of South Florida, USA

Semester abroad as part of the bachelor program

Cognitive Science (BSc)

University of Osnabrück, Germany

Languages

🇩🇪 German

Native proficiency

🇬🇧 English

Full professional proficiency

🇳🇱 Dutch

Full professional proficiency

🇮🇷 & 🇦🇫 Persian

Native proficiency

Looking forward to supporting you in your project

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