Senior Biostatistics Lead: Clinical Strategy & Submissions

IQVIA; Reading; On-site; GBP 80,000 - 120,000; Full time

Job summary

IQVIA in Reading, UK seeks a senior Biostatistician to lead statistics for a therapeutic program. You will define strategy, apply methodologies to trials and regulatory submissions, and collaborate with cross-functional teams to ensure rigorous analyses.

The role calls for strong leadership in study design, regulatory interactions, and delivery of high-quality results for internal and external stakeholders.

Qualifications

• PhD or MS in Biostatistics or related field required.
• Minimum of 8 years in clinical trial statistics, pharma/CRO preferred.
• Strong expertise in SAS/R, Bayesian methods, adaptive designs.

Responsibilities

• Lead full scope of Biostatistics conduct for the program.
• Define statistical strategy and applicable methodologies.
• Influence clinical development plans and governance reviews.
• Provide statistical partnership for Go/No Go criteria and TPS.
• Plan analyses and ensure timely interim/final results.
• Interact with regulatory authorities (FDA/EMA/PMDA).
• Interpret results and ensure reporting accuracy.
• Prepare abstracts, posters, and presentations for stakeholders.

Skills

Biostatistics leadership

Cross-functional collaboration

Statistical planning

Communication of statistics

Education

PhD or MS in Biostatistics, Statistics or related field

Tools

SAS

R

Job description

IQVIA in Reading, UK seeks a senior Biostatistician to lead statistics for a therapeutic program. You will define strategy, apply methodologies to trials and regulatory submissions, and collaborate with cross-functional teams to ensure rigorous analyses.

The role calls for strong leadership in study design, regulatory interactions, and delivery of high-quality results for internal and external stakeholders.