At a Glance
- Tasks: Lead a team in generating clinical evidence and statistical analysis for innovative healthcare solutions.
- Company: Join OGT, a global leader in genomic solutions, based in Cambridge.
- Benefits: Enjoy a competitive salary, bonus scheme, private health insurance, and 25 days holiday.
- Other info: Collaborative environment with opportunities for professional growth and development.
- Why this job: Make a real impact in personalised healthcare and precision medicine.
- Qualifications: Degree in biological sciences; strong statistical skills and experience with R language required.
The predicted salary is between 58500 - 71500 £ per year.
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 Ph D 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.
Medical Affairs Team Lead - Clinical Evidence and Statistics in Cambridge employer: OGT
At OGT, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the field of genomics. Our employees benefit from comprehensive growth opportunities, competitive compensation, and the chance to make a meaningful impact in healthcare across North America. Join us in a role that not only drives your career forward but also contributes to advancing genomic solutions that improve patient outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Affairs Team Lead - Clinical Evidence and Statistics in Cambridge
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like OGT.
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✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at OGT.
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We think you need these skills to ace Medical Affairs Team Lead - Clinical Evidence and Statistics in Cambridge
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at OGT.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at OGT.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to OGT. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at OGT. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at OGT
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research OGT’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
