Director Medical Device jobs

Job Overview
We are seeking an experienced Associate Biostatistical Director to lead advanced statistical analyses within our innovative healthcare research team. The successful candidate will utilize cutting-edge data analysis techniques. The Associate Biostatistical Director will operate as a thought leader in the Biostatistics Department to provide strategic input to Companies product pre-launch and post-launch activities including statistical leadership for IVDR submission and post-market surveillance, and out-of-US clinical studies and regulatory strategy

Responsibilities

• Provide strategic statistical leadership for pre-launch and post-launch product activities, including evidence-generation strategy, study protocol development, statistical analysis plans, implementation of innovative statistical methods, oversight of analyses, and interpretation and dissemination of findings.
• In collaboration with cross-functional teams, lead statistical strategy and reporting for clinical studies and real-world evidence studies supporting IVDR submissions, post-market surveillance/post-market performance follow-up (PMPF), health technology assessments (HTAs), publications, and other regulatory or reimbursement deliverables.
• Partner with Clinical Development, Medical Affairs, Regulatory Affairs, Quality, and other cross-functional stakeholders to shape out-of-US clinical and regulatory strategy, and address ad hoc evidence needs.
• Lead and support studies that leverage registries, claims databases, EMR/EHR, and other post-market and external data sources, as appropriate, to address regulatory, scientific, and business questions.
• Provide statistical leadership for the analysis, thorough review, and interpretation of clinical evidence on diagnostic performance, validity, utility, and longitudinal product performance, and drive cross-functional alignment on findings and their implications.
• Stay abreast of industry and academic developments in the Statistical Genomics, clinical study design and analysis
• Present some of the state-of-the-art statistical methodologies and issues via various departmental and company-wide meetings
• Qualifications
• PhD in Biostatistics or related field with 6+ years, or MS with 8+ years, of relevant academic or industry experience, including substantial experience leading clinical studies, regulatory submissions, and/or post-market evidence generation.
• Molecular diagnostics, IVD/medical device, or pharmaceutical industry experience strongly preferred.
• Familiarity with traditional performance metrics of clinical diagnostic tools
• Strong knowledge of theoretical and applied statistics, including clinical study design and analysis, observational studies, missing data methods, and approaches relevant to regulatory and HTA decision-making.
• Outstanding verbal, written, and presentation skills, with demonstrated ability to influence senior stakeholders and communicate effectively across all levels of the organization and externally.
• Demonstrated success leading the statistical components of pre-launch and/or post-launch product evaluation in the diagnostic/IVD, medical device, or pharmaceutical industry; experience supporting IVDR submissions and post-market surveillance/post-market performance follow-up (PMPF) is strongly preferred.
• Knowledge of applicable regulatory rules and guidelines, including IVDR and associated guidance, ICH/GCP, privacy regulations (e.g., HIPAA/GDPR, as applicable), HTA expectations, and relevant real-world evidence and post-market guidance.
• Experience programming in R or a related statistical programming environment (e.g., SAS), with the ability to guide reproducible analytical workflows and review statistical code

Pay: £105,250.00-£125,550.00 per year

Work Location: Hybrid remote in London EC3V 9DU