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Clinical Research Statistician – Medical Imaging – SaMD – AU
2 months ago
We're 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.
As a Clinical Data Statistician, you will be responsible for assisting with the planning and conduct of research studies supporting the clinical validation of our SaMD products. This will involve informing the study design, statistical analysis, management, and reporting of research study data. You will also be responsible for coordinating interactions between internal and external stakeholders and Subject Matter Experts (SMEs).
We're looking for someone with a strong background in clinical research, biostatistics, or a related field, with experience in research study management, statistical design, data management, and writing clinical reports. You should have excellent oral communication and technical writing skills, as well as the ability to work independently and collaboratively as part of a larger team.
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 our SaMD products.
- 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 harmonized 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 synthesizing 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, organized with the ability to manage multiple projects simultaneously.
We offer a dynamic and supportive work environment, with opportunities for professional growth and development. Our team is passionate about making a difference in people's lives, and we're committed to building inclusive teams that represent a variety of backgrounds and skills.
We're proud to be an Equal Opportunity Employer, and we welcome applications from diverse candidates. If you need any reasonable adjustments or accessibility assistance, please don't hesitate to contact us.
We look forward to hearing from you and exploring how you can contribute to our mission to raise the standard of healthcare for millions of patients every day.
