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Be ready to walk through complex RWE or late-phase analyses you led, justify design and bias-control choices, and explain how you review junior work under FSP timelines. Expect questions on estimands, missing data, and communicating stats risk to non-stat stakeholders.
Strong fit if you are a seasoned biostatistician comfortable owning RWE methodology remotely for pharma clients. Weaker fit if you prefer pure software engineering, early-career pure trial randomization work, or on-site lab science.
As a Principal Biostatistician on an FSP Real-World Evidence engagement at Cytel, you would lead RWE study design, analysis plans, and senior statistical review for sponsor programs. Typical work includes causal methods or observational analyses, programming oversight, cross-functional calls with medical and epidemiology partners, and quality delivery of regulatory-ready outputs.
Strengthen advanced biostatistics for observational/RWE studies, trial and RWE design literacy, and strong R or SAS for analysis pipelines. Domain fluency in pharma evidence generation and clear technical writing matter more here than generic certifications; no specific cert list was provided for this role family.
The posting is marked remote, with a Wyoming location label for Archer/Laramie County rather than a required on-site office.
Functional service provider work embedded with a sponsor, focused on real-world evidence biostatistics rather than only randomized trial ops.
Cytel builds clinical statistics software and delivers CRO-style trial design and biostatistics services to biotech and pharmaceutical developers.
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.
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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, Laramie County, 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…
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