Biostatistics Director: Strategy & Regulatory Submissions

IQVIA; Brussel; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

IQVIA is seeking a senior Biostatistician to lead the statistics for a clinical program. You will define statistical strategy, oversee study design and data analyses, and ensure regulatory submissions are robust.

The role requires 8+ years in clinical trial statistics, expertise in SAS/R, and experience with Bayesian methods and adaptive designs. Collaboration with cross-functional teams and strong communication with regulators are essential.

Qualifications

• PhD or MS in Biostatistics or related field.
• Minimum 8 years in clinical trial statistics, pharma or CRO.
• Strong programming in SAS/R and regulatory experience.

Responsabilités

• Lead full scope of Biostatistics for the responsible program.
• Define statistical strategy and ensure appropriate methods in trials and regulatory submissions.
• Collaborate with cross-functional teams for governance reviews.
• Provide statistical input for innovative study designs and Go/No-Go criteria.
• Represent Biostatistics in interactions with regulatory authorities.
• Interpret results and ensure accuracy in reports and documents.

Connaissances

SAS

R

Bayesian methods

Adaptive design

Regulatory submissions

Leadership

Formation

PhD in Biostatistics

Description du poste

IQVIA is seeking a senior Biostatistician to lead the statistics for a clinical program. You will define statistical strategy, oversee study design and data analyses, and ensure regulatory submissions are robust.

The role requires 8+ years in clinical trial statistics, expertise in SAS/R, and experience with Bayesian methods and adaptive designs. Collaboration with cross-functional teams and strong communication with regulators are essential.