Senior Clinical Data Scientist

About us: Franklin.ai aims to apply the latest methodologies in artificial intelligence (AI) to ultimately put groundbreaking AI tools in the hands of pathologists. Franklin.ai is a joint venture between global medical diagnostic leader Sonic Healthcare (ASX:SHL) and health technology game-changer Harrison.ai with a mission to raise the standard of healthcare for millions of patients every day. Globally, pathology faces a stark skills shortage, with the number of US pathologists decreasing 18% between 2007 and 2017 despite an increase in workload. Building comprehensive AI solutions for pathology will help scale the capacity of diagnostic care across the globe. This new partnership combines Harrison.ai 's depth of expertise and comprehensive AI methodologies with Sonic Healthcare's global clinical experience and distribution. The collaboration will unlock digital pathology to provide pathologists with a second set of eyes, using state-of-the-art AI technology to deliver efficient and accurate diagnosis support. We’re redefining what’s possible in healthcare, through AI technology. About Your Role As a Clinical Data Scientist in the Clinical Affairs Team at Franklin.ai , you will play a key role in both the development and validation of software as medical device (SAMD) artificial intelligence (AI) products in pathology. This role combines data science and biostatistics, offering an opportunity to apply clinical and therapy area knowledge to the design, analysis, and validation of AI models. You will be involved in end-to-end execution of machine learning model performance evaluation studies, and collaborating across teams to produce robust clinical evidence to support the regulatory and marketing strategies for Franklin.ai products. You will provide statistical expertise to a range of critical documents, projects and processes supporting the development and validation of Franklin.ai products. You will reinforce the statistical rigour of the clinical and analytical evidence, contributing to key clinical and regulatory deliverables. What You'll Do: Model Validation: Develop, validate, and deploy standardised tools to assess the quality, accuracy, robustness, and efficacy of AI models, ensuring alignment with regulatory guidelines and industry best practices. Clinical Knowledge Application: Collaborate with clinicians, researchers, and product teams to apply therapeutic area expertise to AI and data analysis, contributing to product and model development (e.g., ontology definition, test set definition). Biostatistics for Validation: Conduct statistical analyses to evaluate the performance of AI models in clinical settings. This includes power analysis for multi-reader multi-case (MRMC) studies or equivalent, contributing to clinical study designs, statistical analysis plans, and preparation of study reports. Cross-Functional Collaboration: Work with cross-functional teams including engineers, clinicians, researchers, and product managers to ensure AI models are evaluated transparently throughout their development lifecycle. Advanced Analytical Approaches: Design and execute complex analyses for clinical validation, analytical validation, and external research studies. Conduct curation, analysis, and interpretation of clinical study data. Clinical Documentation & Reporting: Contribute to clinical study proposals, ethics submissions, protocols, study reports, and manuscripts. Assist in the development of SOPs for clinical research and model validation. External and Internal Stakeholder Management: Manage relationships with external and internal stakeholders, including clinical, regulatory, product, and technical teams, ensuring the successful delivery of research and validation activities. What You Bring: A Master’s degree or PhD in data science, statistics, biostatistics, bioinformatics, computational biology, or a related field. Proven experience working as a data scientist or biostatistician, with a focus on clinical data, healthcare, or AI. Expertise in Python or R (Python preferred), with strong programming skills for data analysis, model evaluation, and automation of analysis workflows. Experience in clinical research, including statistical planning, study design, and data analysis for clinical validation. Strong knowledge of ICH GCP, ISO 14155 and/or ISO 20916. Strong knowledge of regulatory requirements related to clinical studies (FDA, TGA, EU). Excellent communication and interpersonal skills, with a demonstrated ability to collaborate across teams and manage complex discussions and decisions. A proven track record of publishing peer-reviewed research. Bonus Attributes: Experience working in the IVD or medical device industry, particularly with AI, SAMD, or pathology. Experience working in research involving artificial intelligence, SAMD and/or pathology. Experience working with regulatory bodies, including an understanding of regulatory requirements in relation to clinical studies (FDA, TGA, EU). An understanding of reimbursement and health economic analysis. Why join us? Do work that matters: our pioneering Pathology AI solutions will help detect cancer, improve diagnostic accuracy and potentially save millions of lives. Flexible working: we have a remote-first environment with a cool office for social events and brainstorming sessions, or even full-time onsite if you prefer. Grow your career with us: we are believers in lifelong learning. You’ll have access to a variety of resources and continuous career development opportunities. Competitive salary and equity: we’re constantly analysing market rates to keep our compensation up to date, in addition to offering a generous stock options program. Stay at the top of your game: work with diverse teams of industry experts and leaders who are passionate about what they do. Vibrant culture: with sponsored team activities, fun social events and a supportive work environment, your holistic wellbeing is top of mind. What’s next? Thank you for considering becoming part of our team. Please apply now to register your interest and we look forward to reviewing your application shortly. We are proud to be an Equal Opportunity Employer. We celebrate diversity and we are committed to building inclusive teams that represent a variety of backgrounds, perspectives and skills. The more inclusive we are, the better our work will be. All employment is decided on the basis of qualifications, merit and business need. If you need any reasonable adjustments, accessibility assistance or would like to note which pronouns you use at any stage of our hiring process, you may contact us at #J-18808-Ljbffr