Principal Biostatistician – Medical Affairs

Thermo Fisher Scientific

. Provide strategic statistical expertise and oversight across clinical research programmes, particularly Phase IIIb/IV clinical trials, observational studies and patient registries .

Posted 11/5/2026full-timeRemote • France, Greece, Hungary, Netherlands, Italy, Belgium, Poland, United KingdomLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in statistical methodologies and clinical trial design, with a strong focus on evidence generation and regulatory compliance. Proven ability to lead cross-functional teams and communicate complex statistical findings effectively to diverse audiences.

Highest-signal resume keywords

PhD Or MSc In Statistics Or BiostatisticsStatistical Analysis PlanningSAS And R ProficiencyClinical Trial Design ExpertiseGood Clinical Practice (GCP) Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisBiostatistical MethodologiesData InterpretationEvidence GenerationStatistical MethodologiesStatistical Analysis Plans (SAPs)Data Presentation Plans (DPSs)Post-Hoc AnalysesClinical Research OversightPublication Planning

Soft Skills

Excellent Written And Verbal CommunicationStrong Influencing And Negotiation SkillsAnalytical ThinkingProblem-Solving SkillsTeamwork And Collaboration

Industry Keywords

Clinical TrialsObservational StudiesPatient RegistriesPharmaceutical IndustryBiotechnology IndustryRegulatory SubmissionScientific LeadershipCross-Functional CollaborationStakeholder ManagementScientific Excellence

About the role

Key responsibilities & impact

Provide strategic statistical expertise and oversight across clinical research programmes, particularly Phase IIIb/IV clinical trials, observational studies and patient registries
Serve as a key statistical representative within cross-functional teams and provide scientific leadership across multiple studies and projects
Provide statistical expertise and oversight for clinical trials, observational studies, patient registries and other clinical research initiatives
Lead or contribute to clinical study design, statistical analysis planning and interpretation of study results
Develop and review Statistical Analysis Plans (SAPs) and Data Presentation Plans (DPSs)
Support post-hoc analyses, investigator-initiated studies and other research activities
Ensure scientific rigour, statistical integrity and quality of clinical research deliverables
Collaborate with Medical Affairs, HEOR, Epidemiology, Market Access and other functions on evidence-generation strategies
Provide statistical input into product development and regulatory submission-related activities
Support publication planning and scientific communications
Serve as primary statistical contact for external investigators, research partners and vendors
Collaborate on scientific manuscripts, publications, abstracts and conference presentations
Engage with external Key Opinion Leaders (KOLs) on scientific discussions and research initiatives
Communicate complex statistical findings to technical and non-technical audiences
Conduct rigorous statistical analyses for business-critical research questions and evidence-generation activities
Explore and implement innovative statistical methodologies
Identify opportunities to improve statistical approaches, analytical efficiency and scientific value of research outputs
Contribute to continuous improvement of statistical practices and processes

Requirements

What you’ll need

PhD or MSc in Statistics, Biostatistics or a related discipline
Minimum of 6 years of relevant experience for PhD holders or 8 years for MSc holders
Previous experience supporting Medical Affairs statistical activities within the pharmaceutical or biotechnology industry preferred
Experience working independently as a statistical contributor and providing scientific leadership across multiple projects
Experience working within a cross-functional, matrix-based organisation preferred
In-depth working knowledge of SAS and R
Intermediate to advanced expertise in applied biostatistical methodologies, particularly pharmaceutical and clinical research applications
Strong understanding of clinical trial design, statistical analysis, data interpretation and evidence generation
Knowledge of Good Clinical Practice (GCP) and regulatory requirements governing clinical drug development and clinical trials
Ability to apply appropriate statistical methodologies to complex scientific and clinical research questions
Excellent written and verbal communication skills
Experience presenting statistical findings to technical and non-technical audiences, including at public or scientific meetings
Strong scientific writing skills and experience contributing to peer-reviewed publications and journal articles preferred
Ability to build effective relationships and collaborate with internal stakeholders, external investigators and scientific experts
Strong influencing, negotiation and stakeholder-management skills
Ability to manage multiple priorities and projects effectively
Highly organised, proactive and capable of working independently with minimal supervision
Strong analytical thinking, problem-solving skills and attention to detail
Excellent teamwork and collaboration skills
Commitment to scientific excellence, innovation and continuous improvement