Medical Affairs Team Lead - Clinical Evidence and Statistics

An opportunity has arisen in our Cambridge based Medical Affairs team for a Medical Affairs Team Lead - Clinical Evidence and Statistics. The Regulatory and Medical Affairs Directorate is responsible for ensuring that OGT’s products are safe, effective and fit for purpose, thus allowing them to be available globally and state of the art.

The Medical Affairs Team Lead - Clinical Evidence & Statistics is responsible for leading the Clinical Evidence and Statistics function within Medical Affairs. The role provides oversight of clinical evidence generation, study design, statistical operations, data analysis, scientific reporting, and external clinical collaborations to support product development, regulatory submissions, post-market surveillance activities, and commercial objectives.

What you’ll be doing for us

• Line management for Medical Affairs Scientists and Medical Affairs Analysts responsible for clinical evidence generation and statistics
• Set objectives, monitor performance, conduct performance reviews, and support professional development of team members
• Co-ordinate workload allocation and prioritisation across the Clinical Evidence and Statistics team
• Ensure team training, competency records and development plans are maintained
• Lead the planning, design, execution, analysis, and reporting of clinical evidence
• Provide expert input into study design, including protocol development, study objectives, endpoints, sample size considerations and statistical methodologies
• Develop plans to generate clinical evidence through clinical studies, literature reviews, external collaborations, and data acquisition
• Ensure studies are conducted in accordance with approved protocols, SOPs, GCP requirements and applicable regulations
• Support the generation of evidence required for new product development, product modifications and regulatory submissions
• Provide strategic scientific input into product development, regulatory submissions and market access initiatives
• Lead the development and review of study documentation
• Where applicable, ensure studies are executed according to approved protocols, timelines, SOPs and quality requirements
• Oversee study monitoring activities and site interactions where required
• Support audits and inspections relating to clinical evidence activities
• Act as subject matter expert for statistical methodologies and analysis
• Provide statistical guidance across Medical Affairs and other departments as required
• Develop and approve Statistical Analysis Plans
• Oversee statistical analyses performed by the Medical Affairs team
• Oversee study randomisation activities and statistical analysis methodologies
• Review and approve statistical outputs, reports, and conclusions
• Ensure appropriate statistical approaches are applied across all studies and evidence-generation activities
• Support development and maintenance of automated reporting and data analysis workflows, including R-based solutions where appropriate
• Drive continuous improvement of analytical and statistical processes, tools, and reporting methodologies
• Oversee the preparation, review and approval of evidence generation reports
• Ensure scientific accuracy, consistency and regulatory compliance of Medical Affairs outputs
• Contribute to Performance Evaluation Reports and Technical Documentation as required
• Establish and maintain productive relationships with external laboratories, clinicians, healthcare organisations
• Support identification and qualification of external data sources and clinical collaborators
• Provide oversight of externally conducted studies and data collection activities
• Support contracting and study agreement processes
• Ensure Medical Affairs activities are conducted in compliance with ISO 13485, EU IVDR 2017/746, Human Tissue Act requirements, Company SOPs and Quality Management System requirements and Good Clinical Practice (GCP), where applicable
• Contribute to Notified Body inspections, regulatory submissions, audits and responses to regulatory queries
• Support CAPAs, change controls and continuous improvement activities
• Undertake any other duties commensurate with the level and responsibilities of the role as directed by the VP of Medical Affairs.

What we are looking for in you

Essential

• Degree in biological sciences or equivalent
• Knowledge of current GCP/IVD regulations for devices and diagnostics
• Strong statistical understanding and practical experience using R language and other statistical software
• Excellent data interpretation and analytical skills
• Strong scientific writing and review capabilities
• Experience designing, managing and reporting clinical evidence generation studies for IVDs
• Experience authoring and reviewing scientific and clinical documentation for IVDs
• Experience working within an ISO 13485-regulated environment
• Strong stakeholder management and communication skills
• Ability to lead multiple projects simultaneously and deliver to defined timelines
• Ability to influence across departments and effectively lead a evidence generation team.

Desirable

• MSc or PhD in Statistics, Biostatistics, Genetics, Molecular Biology, Clinical Science or related discipline
• Clinical cytogenetics laboratory experience
• Basic knowledge of FISH analysis and processing.

In return you will receive:

• Competitive salary
• Company Bonus Scheme
• Pension Scheme (10% non-contributory)
• Private Health Insurance
• Private Dental Insurance
• Group Income Protection
• Group Life Assurance
• 25 days holiday plus UK bank holidays
• High Street Discount Scheme.