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
