Senior MA and HEOR Biostatistician (m/f/d)

Servier; München; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Company pension

Group accident insurance

Term life insurance

Travel allowance

Underground parking

Bike leasing

Employee PC scheme

Job summary

Servier in Munich seeks a Senior MA and HEOR Biostatistician to lead statistical strategies for Medical Affairs and HEOR evidence generation. The role can be based at the Munich office, with potential for local collaboration across EU markets.

The candidate will provide statistical leadership for payer submissions, author SAPs, oversee analyses for diverse study types, and manage CRO partnerships while ensuring regulatory compliance and high scientific standards.

Qualifications

• Master or PhD in Biostatistics or related field required.
• Experience in MA/HEOR and clinical development.
• Strong knowledge of EU-HTA, ICH, FDA, EMA guidelines.
• Fluency in English (written and spoken).

Responsibilities

• Lead statistical approaches for MA and HEOR evidence generation.
• Provide statistical leadership for JSC, value dossiers, and payer submissions.
• Author SAPs and TLF shells; oversee analyses for post-marketing, retrospective, and observational studies.
• Monitor HTA requirements and update internal practices.
• Review protocols, study reports, and publications for robustness.
• Represent Biostatistics in cross-functional teams; influence decisions.
• Support publication strategy via statistical review of abstracts and posters.
• Oversee CROs and external vendors; ensure regulatory compliance.
• Manage resources and planning for assigned projects.

Skills

Biostatistics

RWE/HTA

SAS

R

Study design

CRO management

English fluency

Education

Master or PhD in Biostatistics

Tools

SAS

R

Job description

Senior MA and HEOR Biostatistician (m/f/d)

We are looking for a Senior MA and HEOR Biostatistician. Due to the company’s international focus, this position is assigned to our head office in France, but can be based at our Munich office.

Key responsibilities:

• Propose and lead the implementation of methodological and statistical approaches for Medical Affairs and HEOR evidence generation across assigned products
• Provide statistical leadership for Joint Scientific Consultations (JSC), value dossiers, and payer submissions, ensuring alignment with EU HTA Regulation requirements
• Author and review Statistical Analysis Plans (SAPs) and TLF shells, overseeing the execution of analyses for post-marketing, retrospective, and observational studies
• Monitor evolving HTA requirements and industry standards, recommending adjustments to internal practices to maintain competitiveness
• Review protocols, study reports, and publications to ensure scientific robustness and consistency across all evidence generation activities
• Represent Biostatistics in cross-functional teams, articulating statistical perspectives to influence strategic decision-making
• Support the publication strategy through the statistical review of abstracts, posters, and manuscripts
• Provide oversight of CROs and external vendors, ensuring adherence to methodological standards and regulatory expectations
• Manage resources and planning for assigned projects, offering scenarios for any identified shortfalls

Qualifications:

• Master’s or Doctoral degree (or equivalent) in Biostatistics, Statistics, or a closely related field
• Several years of experience as a statistician supporting clinical development, Medical Affairs, and HEOR evidence generation
• Strong knowledge of real-world evidence (RWE), indirect treatment comparisons (ITC), and HTA frameworks (e.g., EU-HTA, ISPOR)
• Mastery of regulatory guidelines (ICH, FDA, EMA) and proficiency in SAS and R
• Demonstrated ability to independently determine appropriate study designs and analytical strategies for complex evidence packages
• Proven ability to manage CRO partnerships and provide guidance to non-statistical audiences
• Excellent communication skills with a detail-oriented and well-organized approach to managing multiple projects
• Experience in Oncology is preferred
• Fluency in English (oral and written) is mandatory

What we offer:

A strong sense of community:

Working together as equals in a highly motivated team, characterised by mutual appreciation, respect and tolerance

Ideal environment:

Offices close to the subway, with a variety of local shopping options; Home-Office option; a self-service Cafeteria with a lounge and roof top terrace; free water and coffee

Continual development:

Personalised career development through further training, regular learning sessions – both in person and remotely – such as ‘Lunch & Learn’, scientific product training, yealy development reviews and local talent management, plus optional international training courses from the global Servier & U Academy

Additional benefits:

Company pension scheme, group accident insurance, term life insurance, travel allowance or underground parking, bike leasing and an employee PC scheme as part of deferred compensation, as well as company-wide health initiatives and corporate events, such as Social Day or after-work get-togethers