Provides statistical leadership for Medical Affairs, real-world evidence, comparative effectiveness, HTA, and HEOR activities. Designs and analyzes observational, clinical, Phase IV, and indirect treatment comparison studies; evaluates data quality, bias, uncertainty, and applicability; supports evidence-generation strategies, reimbursement submissions, publications, and scientific communications. Collaborates with statistics, epidemiology, RWE, medical, and external scientific teams to translate complex analyses into actionable conclusions.
Medical Affairs & HTA Statistician
Qualifications
Role Summary
The Medical Affairs & HTA Statistician will provide strategic and technical statistical expertise supporting evidence generation across the product lifecycle, with particular emphasis on Medical Affairs, real-world evidence, comparative effectiveness, and Health Technology Assessment.
The role will translate clinical, observational, and real-world data into scientifically robust evidence addressing questions relevant to patients, clinicians, payers, and healthcare systems. It requires a combination of strong statistical methodology, scientific judgement, strategic thinking, and effective cross-functional communication.
ResponsibilitiesKey Responsibilities
- Provide statistical leadership for Medical Affairs and HTA evidence-generation activities.
- Support development of evidence strategies addressing clinical, patient, payer, and healthcare-system questions.
- Design and analyse observational and real-world evidence studies.
- Apply epidemiological and statistical methodologies to real-world and clinical data.
- Conduct comparative-effectiveness assessments and indirect treatment comparisons.
- Support synthetic-control approaches, Phase IV studies, and other post-approval evidence-generation activities.
- Apply appropriate HTA/HEOR methodologies and contribute statistical expertise to evidence packages supporting access and reimbursement decisions.
- Assess data relevance and quality, quantify and communicate uncertainty, and strengthen the methodological credibility of HTA submissions and scientific discussions.
- Interpret clinical and observational evidence and translate complex analyses into clear scientific conclusions.
- Support publications, congress activities, and other scientific communications where required.
- Apply modern analytical methods, including machine learning, where scientifically appropriate.
- Collaborate with Development Statistics, Epidemiology, Real-World Evidence teams, Medical functions, and external scientific partners.
- Communicate statistical concepts and findings effectively to cross-functional and external stakeholders.
Qualifications
Qualifications & Experience
- Senior-level statistical/biostatistical experience within the pharmaceutical or healthcare environment.
- Demonstrated experience delivering Medical Affairs and/or HTA statistical work packages.
- Broad methodological expertise spanning clinical, observational, and real-world data.
- Strong experience in one or more of: RWE, epidemiological research, comparative effectiveness, indirect treatment comparisons, synthetic controls, HTA/HEOR, or Phase IV research.
- Strong understanding of evidence-generation strategies across the pharmaceutical product lifecycle.
- Ability to assess data quality, methodological limitations, bias, uncertainty, and applicability of evidence.
- Experience communicating statistical findings in publications, scientific discussions, and/or evidence packages.
- Strong scientific judgement, strategic thinking, and stakeholder-management skills.
- Ability to collaborate across multidisciplinary and geographically distributed teams.
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