PRO/COA Biostatistician for JCA Submissions (R)

Lumanity; England; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Competitive salary

Bonus

Pension

Private Healthcare

Dental Cover

Enhanced Eye Care Cover

Electric Car Scheme

Staggered working hours

Job summary

Lumanity is seeking a Biostatistician to execute PRO/COA analyses and contribute to EU JCA submissions under EMA timelines. You will apply MMRM, time-to-deterioration, and estimand frameworks, generating analysis-ready outputs for sponsors and cross-functional teams.

With 3–5 years of hands-on experience, you will work in R within a quality-controlled environment, producing SAPs, analysis specs, and audit-ready documentation while communicating complex results to non-technical stakeholders.

Qualifications

• Master's degree or higher in Biostatistics, Statistics, or related quantitative discipline.
• 3–5 years of experience designing and executing statistical analyses in life sciences consulting or similar.
• Experience analyzing PICOs and PRO/COA endpoints in interventional trials.
• Expertise applying trial-aligned statistical methods for PRO endpoints (e.g., MMRM, ANCOVA) with missing data handling.
• Working knowledge of estimand framework & intercurrent event handling per ICH E9(R1).
• Familiarity with EU HTA Regulation 2021/2282 and JCA process.
• Proficiency in R and reproducible, audit-ready workflows.
• Ability to communicate modeling decisions and limitations to non-technical stakeholders.

Responsibilities

• Executes PRO/COA analyses, and post‑hoc PRO analyses of US trials as directed.
• Performs PRO efficacy analyses including MMRM, ANCOVA, responder analyses, and Time to Deterioration.
• Applies multiple imputation and other missing-data methods to address missingness in longitudinal PRO/COA data.
• Supports development and application of MID thresholds for responder analyses.
• Applies estimand framework principles and intercurrent event handling consistent with ICH E9(R1).
• Conducts subgroup and effect-modification analyses to characterize treatment benefits.

Skills

Statistical analysis

Biostatistics expertise

Science communication

Problem solving

Regulatory knowledge

Education

Master's degree or higher in Biostatistics or related field

Tools

R programming

Job description

Lumanity is seeking a Biostatistician to execute PRO/COA analyses and contribute to EU JCA submissions under EMA timelines. You will apply MMRM, time-to-deterioration, and estimand frameworks, generating analysis-ready outputs for sponsors and cross-functional teams.

With 3–5 years of hands-on experience, you will work in R within a quality-controlled environment, producing SAPs, analysis specs, and audit-ready documentation while communicating complex results to non-technical stakeholders.