• Design and review statistical methodology in protocols and statistical analysis plans. • Lead execution of statistical analyses according to plans and protocols, as well as exploratory or ad-hoc analyses. • Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation. • Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders. • Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams. • Mentor and provide technical supervision to junior team members. • Perform other duties as assigned.

• Perform in a lead Biostatistician role and provide technical expertise as a core team member of high complexity clinical studies, including statistical oversight and attending relevant project meetings. • Provide expert level statistical guidance and thought leadership for innovative study design and clinical development plans, including endpoint selection powering. • Develop the statistical sections of the study protocol for clinical studies. • Responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents. • Conduct overall statistical review of TFLs for clinical studies. • Manage operations work with internal statistical programmers to ensure timeliness and quality of deliverables. • Represent Biostatistics in interactions with regulatory authorities (e.g FDA) and during audits. • Support the preparation of abstracts, oral presentations, manuscripts and written reports by ensuring the results of clinical programs and studies are effectively communicated to internal and external stakeholders. • Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement). • Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization.

• Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out, including feasibility analysis, development of clinical investigation plans, contracts and budgets, timelines, trial oversight, data quality monitoring, and overall study leadership and decision-making. • Contribute to clinical research strategy, ensuring alignment with intended indications, evidence generation plans, and applicable FDA and international regulatory requirements. • Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout. • Provide guidance and lead escalations on complex clinical quality, CRO, or vendor performance issues, advising senior leadership to support sound, well-informed decision-making. • Partner closely across Science collaborators, Product, Engineering, Regulatory, Quality, Clinical Data Management, Legal, and external partners to align study execution with product, clinical, and regulatory goals. • Translate study requirements into operational plans, including protocol-related planning, study-specific documentation, training, reporting needs, and core study management tools such as dashboards, trackers, and decision logs. • Work closely with CROs and data management partners to ensure high-quality and auditable evidence generation across eCRFs, EDC build, data review workflows, data cleaning, and database lock. • Drive study-level strategic decision-making by proactively identifying emerging risks and challenges, developing scenario plans and contingency options, and proposing innovative solutions to keep trials on track when circumstances change. • Help strengthen and maintain Oura’s Quality Management System by contributing to SOPs, templates, work instructions, and repeatable study playbooks. • Identify systemic risks or gaps across the clinical portfolio, not just within a single study, and proactively recommend process changes to leadership. • Mentor and provide operational guidance to Clinical Trial Managers and Clinical Research Coordinators, supporting colleagues as they navigate escalations, ambiguity, and clinical research feedback.

• Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out, including feasibility analysis, development of clinical investigation plans, contracts and budgets, timelines, trial oversight, data quality monitoring, and overall study leadership and decision-making. • Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout. • Partner closely across Science collaborators, Product, Engineering, Regulatory, Quality, Program, Clinical Data Management, Legal, and external partners to align study execution with product, clinical, and regulatory goals. • Translate study requirements into operational plans, including protocol-related planning, study-specific documentation, training, reporting needs, and core study management tools such as dashboards, trackers, and decision logs. • Work closely with CROs and data management partners to ensure high-quality and auditable evidence generation across eCRFs, EDC build, data review workflows, data cleaning, and database lock. • Drive study-level strategic decision-making by proactively identifying emerging risks and challenges, developing scenario plans and contingency options, and proposing innovative solutions to keep trials on track when circumstances change. • Help strengthen and maintain Oura’s Quality Management System by contributing to SOPs, templates, work instructions, and repeatable study playbooks.