Medical Affairs Team Lead - Clinical Evidence and Statistics
OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines.
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.
Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period.
Please note that we will need to establish your right to work during the recruitment process.