Director, Biostatistics FSP

Cytel • United States,

2d

About The Position

The Medical Affairs & HTA Statistician provides strategic and technical statistical expertise to support evidence generation across the product lifecycle, with emphasis on Medical Affairs, real-world evidence, comparative effectiveness, and Health Technology Assessment. The role translates clinical, observational, and real-world data into scientifically robust evidence relevant to patients, clinicians, payers, and healthcare systems. It combines statistical methodology, scientific judgment, strategic thinking, and cross-functional communication.

Requirements

• Senior-level statistical or 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 judgment, strategic thinking, and stakeholder-management skills.
• Ability to collaborate across multidisciplinary and geographically distributed teams.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed