Lead, Clinical Evidence & Statistics

OGT; Cambridge; Presencial; GBP 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Company Bonus Scheme

Private Health Insurance

Group Income Protection

Group Life Assurance

High Street Discount Scheme

Descripción de la vacante

OGT in Cambridge is seeking a Medical Affairs Team Lead to overseeClinical Evidence and Statistics, guiding study design, analysis and reporting to support product development and regulatory submissions.

The role requires strong statistics proficiency (R and software), experience with IVD evidence generation, GCP and ISO13485, and the ability to lead a cross-functional team across external collaborations and internal stakeholders.

Formación

• 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.

Responsabilidades

• Line management for Medical Affairs Scientists and Medical Affairs Analysts.
• 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.
• 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.
• Provide strategic scientific input into product development, regulatory submissions and market access initiatives.
• 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.
• Develop and approve Statistical Analysis Plans.
• Drive continuous improvement of analytical and statistical processes, tools, and reporting methodologies.
• Oversee the preparation, review and approval of evidence generation reports.

Conocimientos

Statistical analysis

R language

Data interpretation

Scientific writing

Educación

MSc/PhD in Statistics

Clinical Science related degree

Herramientas

R

Statistical software

Descripción del empleo

OGT in Cambridge is seeking a Medical Affairs Team Lead to overseeClinical Evidence and Statistics, guiding study design, analysis and reporting to support product development and regulatory submissions.

The role requires strong statistics proficiency (R and software), experience with IVD evidence generation, GCP and ISO13485, and the ability to lead a cross-functional team across external collaborations and internal stakeholders.