Director, Biostatistics FSP

Cytel; Denver (CO); On-site; USD 120,000 - 190,000; Full time

Job summary

Cytel is seeking a Medical Affairs & HTA Statistician to provide strategic and technical statistical expertise across the product lifecycle, with emphasis on Medical Affairs, real-world evidence, comparative effectiveness, and Health Technology Assessment.

The role translates clinical and observational data into scientifically robust evidence for patients, clinicians, payers, and health systems, requiring strong statistical methodology, scientific judgement, and effective cross-functional

Qualifications

• Senior-level statistical/biostatistical experience in pharma or healthcare.
• Experience delivering Medical Affairs/HTA statistical work packages.
• Broad methodological expertise across clinical, observational, and real-world data.

Responsibilities

• Provide statistical leadership for MA and HTA evidence-generation activities.
• Support evidence strategies addressing clinical, payer, and healthcare-system questions.
• Design and analyse observational and real-world evidence studies.
• Apply epidemiological and statistical methods to real-world and clinical data.
• Conduct indirect treatment comparisons and comparative-effectiveness assessments.
• Support post-approval evidence-generation activities including synthetic controls and Phase IV.
• Apply HTA/HEOR methodologies to evidence packages for access and reimbursement.
• Assess data quality, uncertainty, and methodological credibility in HTA submissions.

Skills

Statistical leadership

Biostatistics

Publications & scientific comms

Cross-functional collaboration

HTA/HEOR knowledge

RWE/Real-world data

Phase IV studies

Epidemiology

Tools

R

SAS

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.