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

Note: The job is a remote job and is open to candidates in USA. reputed company 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

• reputed company for strategy and execution of reputed company 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 reputed company statistical design for reputed company or reputed company studies, introducing innovative methodologies
• You ensure strategic alignment and quality across statistical deliverables in programs or submissions
• You solve reputed company 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 reputed company and clarity
• You reputed company 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 reputed company 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 reputed company 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 reputed company and/or R with deep familiarity with CDISC standards and evolving regulatory data requirements
• You demonstrate reputed company for independent thinking and ability to reputed company 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 reputed company 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 reputed company technical concepts in clear language
• You are able to effectively partner with stakeholders reputed company and reputed company of PDD
• 5+ years' experience in Biostatistics & reputed company
• Experience with Late Phase
• Independent trial statistician experience
• Experience working in cross-functional global study teams
• Effective communication skills with the ability to translate reputed company 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 reputed company data for non-technical stakeholders
• Experience in mentoring or scientific leadership reputed company a matrix organization
• Strategic reputed company 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 reputed company 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.reputed company.com.

Company H1B Sponsorship

• reputed company 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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