Principal Biostatistician FSP – Vaccines

Cytel is recruiting a Principal Biostatistician to lead statistical strategy and clinical trial design for vaccine development initiatives. This is a full-time position based in India, structured as a dedicated assignment embedded with a pharmaceutical sponsor.

Position Summary

As Principal Biostatistician FSP (Full-Time Secondment Program), you will serve as the statistical lead for vaccine development and clinical trial programs, working directly with a pharmaceutical client in an embedded consultancy role. You'll drive statistical innovation, mentor biostatisticians, and shape clinical development strategy in the vaccines therapeutic area. This role combines independent statistical leadership with close collaboration on sponsor initiatives, requiring both strategic vision and hands-on analytical expertise.

Key Responsibilities

• Develop statistical analysis plans, protocols, and design strategies for clinical vaccine trials
• Lead biostatistical teams and provide mentorship to junior statisticians
• Oversee data management, quality assurance, and statistical programming activities
• Prepare regulatory submissions and statistical sections for clinical development reports
• Collaborate with clinical, safety, and operations teams to advance program objectives
• Ensure compliance with regulatory guidelines and industry standards throughout trial execution
• Drive statistical methodology innovation and best practices within vaccine development programs

Requirements

• Master's or PhD degree in Biostatistics, Statistics, or a related quantitative discipline
• Substantial clinical trial biostatistical experience
• Experience with vaccine trial design or immunogenicity analysis
• Proficiency with statistical software (SAS, R, or equivalent)
• Strong knowledge of ICH-GCP guidelines and regulatory requirements
• Proven leadership experience managing biostatistical teams
• Excellent written and verbal communication skills, with the ability to present statistical findings to clinical and non-technical audiences

Why Join Cytel

Cytel is the global leader in biostatistics and clinical trial services, trusted by pharmaceutical sponsors to advance drug and vaccine development. You'll work on high-impact programs in vaccines, collaborating with top clinical and scientific talent across the organization. We invest in professional development, foster innovation, and offer the opportunity to shape regulatory science and clinical development strategy at a principal level.

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.