Senior Biostatistician, MA/HEOR – Evidence Strategy

Servier Group; France; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Servier Group is seeking a Biostatistician to lead statistical support for Medical Affairs and HEOR evidence generation. You will contribute to HTA submissions, value dossiers, and regulatory interactions, leveraging expert methodologies and collaboration with cross-functional teams.

The role emphasizes SAP development, study design, and overseeing external vendors to ensure scientific rigor and alignment with payer expectations.

Qualifications

• Master’s or Doctoral degree in Biostatistics or related field.
• 8+ years of experience supporting clinical development, Medical Affairs, and HEOR.

Responsibilities

• Provide expert statistical support for Medical Affairs and HEOR evidence plans.
• Lead as Biostatistics representative for IEGP, JSC, and JCA dossiers.
• Collaborate with HEOR to contribute clinical evidence for value dossiers and payer submissions.
• Champion innovative statistical methodologies to address evidence gaps.
• Monitor evolving HTA requirements and regulatory guidance.
• Provide statistical support for HTA analyses, post-marketing, observational studies, and PROs.
• Author and review SAPs with TLF shells; oversee analyses and interpretation.
• Review protocols, study reports, and publications for robustness.
• Represent Biostatistics in cross-functional teams and regulatory interactions.
• Oversee CROs and external statisticians to ensure compliance.
• Contribute to SOPs and departmental process improvements.

Skills

Statistical expertise

HTA knowledge

CRO management

Communication

Project management

Leadership

Regulatory insight

Education

Master's or Doctoral degree in Biostatistics

Tools

SAS

R

Job description

Servier Group is seeking a Biostatistician to lead statistical support for Medical Affairs and HEOR evidence generation. You will contribute to HTA submissions, value dossiers, and regulatory interactions, leveraging expert methodologies and collaboration with cross-functional teams.

The role emphasizes SAP development, study design, and overseeing external vendors to ensure scientific rigor and alignment with payer expectations.