[Remote] Principal Biostatistician (Remote: USA/Canada)

Note: The job is a remote job and is open to candidates in USA. Cytel is a leading company in biostatistics and clinical trial analysis, seeking a Principal Biostatistician. This role involves applying statistical expertise to ensure the scientific rigor and regulatory compliance of clinical trials, contributing to protocol development, and leading statistical design for studies.

Responsibilities

• You are accountable for strategy and execution of all statistical aspects of a molecule program
• You ensure the application of digital, design, and data capabilities at the molecule program level
• You represent PDD on cross-functional teams, such as the Development and Lifecycle Team
• You ensure consistency, scientific rigor, and regulatory readiness of statistical deliverables, including protocols, statistical analysis plans, outputs, and submissions
• You contribute to internal and external scientific communication, including publications, presentations, and engagement with methodological communities
• You lead statistical design for complex or priority studies, introducing innovative methodologies
• You ensure strategic alignment and quality across statistical deliverables in programs or submissions
• You solve complex statistical challenges using deep expertise and novel approaches
• You represent the function in strategic cross-functional teams, discussions, and decision-making forum
• You interpret and drive the narrative of key results for internal and external stakeholders
• You own statistical content in major regulatory submissions, ensuring integrity and clarity
• You lead sub-streams or functional contributions in global or large-scale cross-functional initiatives
• You mentor junior staff

Skills

• You hold a PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field
• You have 6+ years of experience in clinical trial statistics, including responsibility for study-level strategy and decision-making
• You have a proven ability to lead statistical input into clinical development plans and regulatory submissions
• You bring strong expertise in applying advanced statistical methods to support data-driven decision-making
• You are proficient in SAS and/or R with deep familiarity with CDISC standards and evolving regulatory data requirements
• You demonstrate capacity for independent thinking and ability to make decisions based upon sound principles
• You bring excellent strategic agility including problem-solving and critical thinking skills, and agility that extends beyond the technical domain
• You demonstrate respect for cultural differences when interacting with colleagues in the global workplace
• You have excellent verbal and written communication skills, specifically in the areas of presentation and writing, with the ability to explain complex technical concepts in clear language
• You are able to effectively partner with stakeholders within and outside of PDD
• 5+ years' experience in Biostatistics & SAS
• Experience with Late Phase
• Independent trial statistician experience
• Experience working in cross-functional global study teams
• Effective communication skills with the ability to translate complex statistical concepts for non-statistical audiences
• Experience with multiple phases of drug development (early and/or late stage)
• Excellent communication skills, including the ability to influence and translate complex data for non-technical stakeholders
• Experience in mentoring or scientific leadership within a matrix organization
• Strategic mindset with the ability to contribute to portfolio-level decisions
• Would be good to have R

Company Overview

• Our mission is to improve success rates in this endeavor via the optimal design, effective implementation It was founded in 1987, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is http://www.cytel.com.

Company H1B Sponsorship

• Cytel has a track record of offering H1B sponsorships, with 35 in 2025, 54 in 2024, 37 in 2023, 46 in 2022, 43 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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