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Lead Biostatistician - Job Opportunity at Thermo Fisher Scientific

Home Office, Germany
Full-time
Senior
Posted: August 17, 2025
Remote
EUR 85,000 - 120,000 annually based on the senior-level requirements, specialized biostatistics expertise, and EMEA market positioning. The role's involvement in multiple clinical trials and regulatory submissions, combined with Thermo Fisher Scientific's market position, suggests compensation in the upper portion of this range with additional performance-based incentives.

Benefits

Competitive salary with extensive benefits package positioning you ahead of industry standards
Comprehensive professional development opportunities within a globally recognized scientific organization
Cross-disciplinary team collaboration exposure enhancing career versatility
Dynamic work environment in a rapidly growing biotech sector with high innovation potential
Remote work flexibility supporting work-life balance in a results-oriented culture
Access to cutting-edge clinical research spanning 100+ countries expanding global expertise
Involvement in breakthrough therapeutic development with direct patient impact

Key Responsibilities

Drive statistical excellence across multiple clinical trials as the primary biostatistical expert, directly influencing drug development success and regulatory approval outcomes
Lead cross-functional collaboration with program partners and stakeholders to deliver critical statistical deliverables that shape clinical trial strategy and execution
Provide strategic statistical expertise for clinical development plans and compound programs, positioning treatments for successful market entry
Contribute to regulatory authority submissions through advanced statistical analysis and documentation, directly impacting drug approval processes
Execute functional leadership responsibilities within regulatory frameworks, ensuring compliance while maintaining scientific rigor
Mentor and guide statistical processes across multiple concurrent clinical trials, maximizing operational efficiency and scientific validity

Requirements

Education

Master or doctorate (Ph.D.) degree in Statistics or related field

Experience

Minimum of 5 years experience (which may include doctoral research in field of biostatistics)

Required Skills

expertise in drug development demonstrated track record of advanced knowledge of biostatistics strong command of biostatistics application to clinical trials ability to plan, supervise, implement and monitor statistical processes for multiple clinical trials proficiency in statistical software (SAS and/or R) ability to collaborate with program partners and stakeholders ability to clearly explain complex statistical concepts in written and spoken English team-player with focused attitude ability to work autonomously as part of a cross-disciplinary team
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Sauge AI Market Intelligence

Industry Trends

The biostatistics field is experiencing unprecedented growth driven by the expansion of personalized medicine and precision therapeutics, with companies increasingly requiring statisticians who can handle complex biomarker-driven trial designs and adaptive clinical trial methodologies. The integration of real-world evidence and digital health technologies is creating new statistical challenges that require advanced expertise in novel analytical approaches. Regulatory agencies are placing greater emphasis on statistical rigor and transparency, particularly in the wake of accelerated approval pathways and breakthrough therapy designations. This trend is driving demand for senior biostatisticians who can navigate complex regulatory landscapes while maintaining scientific integrity. The autoimmune therapeutics market is experiencing rapid expansion, with biologics and targeted therapies requiring sophisticated statistical modeling approaches. Companies are seeking biostatisticians with specific expertise in immunology endpoints and biomarker analysis to support increasingly complex trial designs. Remote work capabilities have become essential in the post-pandemic biostatistics landscape, with companies expanding their talent pools globally while maintaining high standards for collaboration and deliverable quality.

Role Significance

Typically manages statistical deliverables across 3-5 clinical programs simultaneously, collaborating with cross-functional teams of 15-25 professionals including clinical operations, regulatory affairs, medical affairs, and data management specialists.
This is a senior individual contributor role with significant strategic impact, evidenced by the responsibility for multiple clinical trials, regulatory submissions, and cross-functional leadership. The position requires autonomous decision-making capabilities while reporting to franchise leadership, indicating substantial professional authority within the organization.

Key Projects

Phase II and Phase III clinical trials in autoimmune therapeutics requiring complex statistical designs and interim analyses Regulatory submission packages including statistical analysis plans, integrated summaries of efficacy and safety, and responses to regulatory queries Adaptive trial designs incorporating futility and efficacy stopping rules for resource optimization Biomarker strategy development and validation studies supporting companion diagnostics Real-world evidence studies and post-market surveillance analyses supporting lifecycle management

Success Factors

Deep expertise in clinical trial methodology combined with practical experience in regulatory submission processes, as the role demands both statistical rigor and regulatory acumen to navigate complex approval pathways successfully. Exceptional communication skills enabling effective translation of complex statistical concepts to diverse stakeholders, from clinical investigators to regulatory reviewers, ensuring alignment and buy-in across all project phases. Strong project management capabilities with the ability to prioritize and execute multiple concurrent deliverables under tight timelines, particularly critical in the fast-paced biotech environment where speed to market directly impacts competitive positioning. Collaborative leadership style that builds strong working relationships across disciplines while maintaining statistical independence and scientific integrity, essential for influencing without direct authority. Continuous learning mindset to stay current with evolving regulatory guidance, statistical methodologies, and therapeutic area developments, particularly in the rapidly advancing autoimmune disease space.

Market Demand

High demand driven by the expanding clinical research sector, particularly in autoimmune therapeutics and personalized medicine, with a notable shortage of senior biostatisticians capable of handling multiple concurrent programs and regulatory submissions.

Important Skills

Critical Skills

Advanced SAS and R programming skills are absolutely essential as these platforms form the foundation of all statistical analysis and regulatory submission activities. Proficiency must extend beyond basic analysis to include complex programming for adaptive designs, simulation studies, and integrated analyses across multiple studies. Deep understanding of ICH guidelines and regulatory requirements is critical for ensuring all statistical deliverables meet submission standards and can withstand regulatory scrutiny. This includes expertise in statistical analysis plans, integrated summaries, and responses to regulatory questions. Clinical trial design expertise encompassing sample size calculations, randomization strategies, and statistical analysis methodologies is fundamental to the role's success, as these decisions directly impact trial feasibility and regulatory approvability.

Beneficial Skills

Machine learning and artificial intelligence applications in clinical research are becoming increasingly valuable as the industry adopts predictive modeling and patient stratification approaches Real-world evidence methodology and health economics expertise are growing in importance as regulatory agencies and payers seek comprehensive evidence packages beyond traditional clinical trials Therapeutic area specialization in immunology and autoimmune diseases would provide significant competitive advantage given the client focus and the complexity of immunological endpoints and biomarker analyses

Unique Aspects

Direct involvement in autoimmune therapeutics development, a rapidly expanding therapeutic area with high unmet medical need and significant commercial potential
Integration within Thermo Fisher Scientific's comprehensive clinical research ecosystem, providing exposure to diverse therapeutic areas and development stages beyond the primary assignment
Opportunity to influence statistical strategy for a global mid-sized biotech client, offering entrepreneurial experience within a large organization framework
Remote work flexibility combined with European regional focus, enabling work-life balance while maintaining proximity to key regulatory and clinical centers
Access to cutting-edge statistical methodologies and technologies through Thermo Fisher's investment in digital clinical trial capabilities

Career Growth

Progression to Principal level typically occurs within 2-3 years with strong performance, while advancement to Director-level positions generally requires 4-6 years of demonstrated leadership success and strategic impact.

Potential Next Roles

Principal Biostatistician with expanded therapeutic area responsibility and junior staff oversight Biostatistics Director overseeing statistical strategy across multiple compounds and development programs Head of Statistical Sciences with full departmental leadership and strategic planning responsibilities Regulatory Affairs Director leveraging statistical expertise in regulatory strategy and agency interactions

Company Overview

Thermo Fisher Scientific

Thermo Fisher Scientific stands as a global leader in serving science with over $40 billion in annual revenue, combining laboratory equipment, consumables, software, and services to enable customers across pharmaceutical, biotech, academic, and government sectors. The company's PPD clinical research division represents one of the world's largest contract research organizations, providing comprehensive drug development services from preclinical through post-market phases.

Market leadership position in the life sciences tools and services sector, with strong competitive advantages in integrated service offerings and global operational scale. The company's recent acquisitions and organic growth have solidified its position as a premier partner for biotech and pharmaceutical companies seeking comprehensive clinical development support.
Strong EMEA presence with significant operations in Belgium, Germany, and the UK, supported by regulatory expertise specific to European Medicines Agency requirements and local country registrations. The regional focus on autoimmune therapeutics aligns with European centers of excellence in immunology research.
Science-driven culture emphasizing innovation and collaboration, with significant investment in employee development and career progression. The company's mission-focused approach creates an environment where scientific rigor and patient impact are prioritized, while the scale provides resources and stability for long-term career growth.
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