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Clinical Research Statistician – Medical Imaging – Data Scientist – Harrison
2 months ago
We are seeking a highly motivated and experienced Clinical Data Statistician to join our Clinical Research and Medical Affairs team at Harrison. As a key member of our team, you will play a vital role in supporting the clinical validation of software as medical device (Sa MD) artificial intelligence (AI) products used in diagnostic medical imaging.
Key Responsibilities- Support the development of research study protocols and reports, as well as other associated study documentation.
- Assist with end-to-end study management activities, including development of study concept and design, site and SME engagement, study monitoring and ongoing risk management.
- Contribute to the statistical analysis plan and advocate for innovative strategies to evaluate the performance of Sa MD.
- Develop, maintain, and validate scripts for statistical analysis or formatting of study results.
- Contribute to the evidence dissemination strategy by presenting study results in conference abstracts and/or high-quality manuscripts for peer-reviewed publication.
- Effectively manage liaisons between internal and external stakeholders from cross-functional teams.
- Perform quality assurance and manage document reviews, ensuring all documents are well organized, scientifically accurate, consistent, and in compliance with applicable Standard Operating Procedures (SOPs), guidelines and regulations.
- Complete research studies and associated documentation within a period that supports the product roadmap and deadlines.
- Bachelor's degree in a scientific or related field (e.g., medical sciences, pharmacology, engineering, statistics).
- 1-3 years of experience in clinical research, biostatistics, or a related function within the pharmaceutical, biotechnology, or medical device industry.
- Knowledge of Good Clinical Practice or other harmonised standards.
- Understanding of clinical research study design, statistics, protocol development and study management activities.
- Experience in a statistical programming language such as R or Python.
- Demonstrable skills in data wrangling/cleaning, and analysis of clinical data; and in interpreting, critiquing, and synthesising statistical results.
- Excellent oral communication and technical writing skills.
- Able to work independently as well as collaborate within a larger team.
- Strong interpersonal skills and experience managing stakeholders from cross-functional teams.
- Detail-oriented, organised with the ability to manage multiple projects simultaneously.
- Masters/Ph D or post-graduate qualification in a relevant area of medical science.
- Experience evaluating machine learning models, or working in Sa MD, radiology or related medical imaging field.
- Familiarity with clinical evaluation processes and other regulatory compliance requirements in major markets (EU, US, and Australian Medical Device Regulations).
- Established publication record.
We are a technology company pioneering new ways of improving health delivery at scale using the latest AI technologies. Our mission is to raise the standard of healthcare for millions of patients every day. We are a global company with a presence across APAC, EU and US regions, and we are backed by I-MED radiology and other leading investors. We are committed to building inclusive teams that represent a variety of backgrounds and skills, and we are proud to be an Equal Opportunity Employer.
