Director, Biostatistics FSP

Cytel; Austin (TX); On-site; USD 140,000 - 190,000; Full time

Job summary

Cytel Inc. seeks an experienced Medical Affairs & HTA Statistician to provide strategic statistical expertise across the product lifecycle, emphasizing real-world evidence and HTA considerations.

You will translate clinical, observational, and real-world data into robust evidence for patients, clinicians, payers, and health systems. You will lead observational studies, apply HTA/HEOR methodologies, and collaborate with cross-functional teams to strengthen evidence packages for access and

Qualifications

• Senior-level statistical/biostatistical experience in pharma or healthcare.
• Experience delivering Medical Affairs and/or HTA statistical work packages.
• Broad methodological expertise across clinical, observational, and real-world data.
• Experience in RWE, epidemiological research, comparative effectiveness, indirect treatment comparisons, synthetic controls, HTA/HEOR, or Phase IV.
• Ability to assess data quality, limitations, bias, uncertainty, and applicability of evidence.
• Experience communicating statistical findings in publications or discussions.
• Strong scientific judgement, 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 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 methodological credibility of HTA submissions.
• Interpret clinical and observational evidence and translate 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 partners.
• Communicate statistical concepts and findings effectively to cross-functional and external stakeholders.

Skills

Senior biostatistician

Medical Affairs HTA

Observational/RWE analysis

Comparative effectiveness

Indirect treatment comparisons

HTA/HEOR

Phase IV research

Cross-functional collaboration

Statistical communication

Job description

Medical Affairs & HTA Statistician

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.

Key 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 & 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.

Cytel Inc. is an Equal Employment / Affimative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.