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Principal Biostatistician FSP – Vaccines

Cytel · India

How to use this kit

Ground every answer in facts on this page and the original listing. We never invent Glassdoor-style reviews or salaries that are not in our data.

Interview prep

Be ready to discuss vaccine trial designs, multiplicity and interim analysis, estimands, and how you lead statistical strategy under an FSP model. Reference Cytel’s CRO-plus-software positioning and Solara-style strategy tools only if you can speak from experience or public knowledge—not invented metrics.

Fit summary

Strong fit if you are a senior biostatistician with vaccine or infectious-disease trial depth who wants principal-level ownership inside a stats-led CRO. Weaker fit if you prefer pure software engineering or non-clinical stats without FSP client accountability.

Day in the role

As a Principal Biostatistician FSP focused on vaccines at Cytel, the day centers on study design and analysis for vaccine programs: adaptive or fixed designs, endpoints, interim looks, and SAP input; coding and reviewing analyses; cross-functional work with clinical, data management, and client teams; and senior review of outputs for regulatory-ready packages.

Skills to emphasize

Prioritize advanced biostatistics for vaccines, trial design software and methods Cytel is known for, SAS/R for analysis, ICH/regulatory stats practice, and clear client-facing FSP communication. No certification list was supplied for this role family.

FAQ from this listing

What does Cytel do?

Cytel builds statistical software and provides clinical trial design and biostatistics services for biotech and pharmaceutical development, founded in 1987.

Is this role remote?

The listing is for India and is not marked remote (remote flag 0), so plan for a local India-based arrangement unless Cytel states otherwise in the full posting.

What is the FSP angle?

FSP typically means embedded biostatistics support for a sponsor’s vaccine portfolio while remaining a Cytel employee—principal ownership of methods, analysis quality, and client partnership.

Company facts (cached)

Website: cytel.com

Cytel is a multinational statistical software developer and contract research organization, headquartered in Cambridge, Massachusetts, USA. Cytel provides clinical trial design and implementation services, and statistical software products primarily for the biotech and pharmaceutical development markets.

Public cache only — not an employee review.

Role overview (listing rewrite)

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.

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Generated for personal interview prep · 2026-07-19 UTC · getajob.ai