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Be ready to walk through a pivotal trial you led: design tradeoffs, multiplicity, missing data, interim looks, and how you explained results to clinical and regulatory partners. Expect scenario questions on SAP decisions, DMC interactions, and working inside an FSP model with sponsor stakeholders.
Strong fit if you already operate as a senior clinical biostatistician who can own sponsor deliverables independently. Less ideal if you prefer pure software product work over FSP study delivery, or if you need on-site life-sciences density beyond Concord’s scale.
As a Principal Biostatistician FSP at Cytel, a typical day centers on study design and analysis for sponsor-facing clinical programs: SAP and protocol input, adaptive or complex designs, analysis datasets and reporting, DMC support, and mentoring junior statisticians while aligning with Cytel’s software and CRO methods.
Prioritize deep clinical trial methodology, regulatory statistics (FDA/EMA expectations), SAS/R for analysis and reporting, and FSP client communication. No certification list was provided for this family; focus on demonstrated trial leadership and adaptive/complex design experience over generic credentials.
Cytel builds statistical software and provides CRO-style clinical trial design and analysis services for biotech and pharmaceutical development, per its public company profile.
The listing marks remote as off and places the job in Concord, Merrimack County, New Hampshire; confirm hybrid or office expectations with the recruiter.
FSP typically means Functional Service Provider—you work embedded with a sponsor’s stats program while employed by Cytel, not as a pure internal product-only biostatistician.
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.
Cytel is hiring a full-time Principal Biostatistician FSP in Concord, Merrimack County, to drive the statistical strategy behind late-phase Immunology clinical trials. If you thrive on shaping rigorous study designs and turning complex data into clear, actionable insight, this on-site role offers the chance to lead at the heart of cutting-edge drug development. About the Role As a Principal Biostatistician FSP at Cytel, you will own the statistical activities that support late-phase Immunology clinical trials. Working on-site in Concord, Merrimack County, you will provide statistical leadership across the full study lifecycle, from early design through final interpretation of results. Key Responsibilities Provide statistical leadership for late-phase Immunology clinical studies. Contribute to study designs that align with scientific and regulatory objectives. Develop study protocols and statistical analysis plans. Review and interpret the analysis of clinical study data. Plan and carry out ad hoc and exploratory analyses as study needs arise. Qualifications Demonstrated expertise in biostatistics applied to clinical trials, ideally within late-phase research. Hands-on experience authoring study protocols and statistical analysis plans. Strong ability to interpret and communicate statistical findings to cross-functional teams. Capacity to operate as a statistical leader on complex clinical programs. Background supporting Immunology or comparable therapeutic areas is advantageous. About Cytel Cytel partners with the world's leading biopharmaceutical organizations to advance clinical research through statistical excellence and functional service provider (FSP) solutions. Joining Cytel means becoming part of a team that values methodological rigor, scientific curiosity, and meaningful contributions to patient health. How to Apply Ready to take the next step in your biostatistics career? Submit your application for the Principal Biostatistician FSP position at Cytel in Concord, Merrimack County through the official listing here via Adzuna.
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