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Clinical Research Statistician – Medical Imaging – SaMD – AU: Unlocking the Power of AI in Healthcare
2 months ago
We are seeking a highly motivated and experienced Clinical Data Statistician to join our Clinical Research and Medical Affairs team. As a key member of our team, you will play a vital role in supporting the clinical validation of software as medical device (SaMD) 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 SaMD.
- 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.
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
- The chance to work on cutting-edge AI projects that have the potential to make a real difference in people's lives.
