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

ServierMunich, BavariaHybrid, On-siteFull-timeSenior, 5–8 yearsListed 3 days ago

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About this role

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.

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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

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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