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.