Principal Biostatistician FSP – RWE – Remote

Join Cytel as a Principal Biostatistician specializing in Full Service Package (FSP) deliverables and Real-World Evidence (RWE) strategy. This full-time remote position is based in Archer, and offers the opportunity to lead complex biostatistical initiatives for life sciences organizations worldwide.

About the Role

As Principal Biostatistician FSP, you will drive the strategic direction and technical execution of biostatistical programs for clients in the pharmaceutical, medical device, and life sciences sectors. This leadership role combines hands-on analytical expertise with team oversight, regulatory insight, and business development responsibilities. You'll shape how Cytel delivers statistical excellence across real-world evidence studies, clinical trials, and health economics research.

What You'll Do

• Oversee end-to-end biostatistical strategy and execution for FSP engagements, ensuring alignment with client objectives and regulatory requirements
• Lead RWE study design, data analysis, and interpretation using advanced statistical methodologies and real-world data sources
• Mentor and supervise biostatistics team members, fostering professional development and technical excellence
• Engage directly with clients to translate business questions into rigorous statistical approaches
• Develop statistical analysis plans, ensure protocol compliance, and support regulatory submissions
• Contribute to proposal development and bid strategy for new client opportunities

What We're Looking For

• Advanced degree in biostatistics, statistics, or related quantitative field (MS or PhD preferred)
• 10+ years of biostatistics experience in pharmaceutical, clinical research, or life sciences environments
• Deep expertise in real-world evidence methodology and RWE data sources
• Proven leadership experience managing biostatistical teams and stakeholder relationships
• Strong knowledge of regulatory frameworks (FDA, ICH, EMA guidance)
• Demonstrated ability to communicate statistical concepts to non-technical audiences
• Proficiency in statistical software (SAS, R, or equivalent)

About Cytel

Cytel is a leader in biostatistics, health economics, and operations research services and software for the life sciences industry. We combine deep domain expertise with innovative thinking to solve complex problems in drug development and real-world evidence. At Cytel, we invest in our people, creating an environment where experienced professionals grow into senior leaders and make meaningful contributions to global health innovation.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.