Biostatistician — PRO/COA Analytics & JCA Dossiers

Lumanity; Greater London; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Private Healthcare

Pension

Dental Cover

Electric Car Scheme

Staggered working hours

Job summary

Lumanity is seeking a Biostatistician to execute statistical analyses of PRO/COA endpoints in support of regulatory submissions and consulting timelines. You will work with the Director, Biostatistics to implement MMRM, ANCOVA, and responder analyses, applying estimand framework and missing-data methods within R-based tooling.

The role involves developing analysis plans, documents for JCA dossiers, and translating complex statistical results into clear, decision-ready outputs for Sponsors and

Qualifications

• Master's degree or higher in Biostatistics, Statistics, Quantitative Psychology/Psychometrics, or related quantitative discipline.
• 3-5 years of experience designing and executing statistical analyses in life sciences consulting or similar.
• Experience analyzing PRO/COA endpoints in interventional trials and translating results for stakeholders.
• Proficiency in R for statistical programming with end-to-end workflows.
• Familiarity with ICH E9(R1) estimand framework and EU HTA/JCA processes.

Responsibilities

• Executes PRO/COA analyses and post-hoc PRO analyses as directed by the Director, Biostatistics.
• Performs PRO efficacy analyses (MMRM, ANCOVA, responder analyses, Time to Deterioration).
• Applies missing-data methods and multiple imputation.
• Contributes to SAPs, analysis specifications, and evidence-synthesis documents.
• Interprets results and prepares decision-ready reports for technical and non-technical audiences.

Skills

R programming

Statistical analysis

JCA knowledge

Communication with stakeholders

Quality-controlled workflows

Education

MSc or PhD in Biostatistics

Tools

R

Job description

Lumanity is seeking a Biostatistician to execute statistical analyses of PRO/COA endpoints in support of regulatory submissions and consulting timelines. You will work with the Director, Biostatistics to implement MMRM, ANCOVA, and responder analyses, applying estimand framework and missing-data methods within R-based tooling.

The role involves developing analysis plans, documents for JCA dossiers, and translating complex statistical results into clear, decision-ready outputs for Sponsors and