Statistician

Roche

. Contribute to trial design under guidance using standard statistical methods .

Posted 11/9/2026full-timeShanghai • ChinaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis and clinical trial design, with proficiency in SAS and/or R, and a strong understanding of ICH guidelines and regulatory requirements. Capable of collaborating effectively within cross-functional teams while maintaining high standards of communication and methodological rigor.

Highest-signal resume keywords

MSc Or PhD In StatisticsClinical Trial Statistics ExperienceProficiency In SAS And/or RFamiliarity With ICH GuidelinesStatistical Analysis Plans Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisClinical Trial DesignStatistical PrinciplesStatistical MethodologyData AnalysisProtocol DraftingCase Report Forms DevelopmentStatistical Analysis PlansRegulatory ResponsesCDISC Standards

Soft Skills

Problem-SolvingCritical ThinkingIndependent ThinkingExcellent CommunicationCultural Respect

Industry Keywords

BiostatisticsPharmaceuticalBiotechCROGCPFDAEMAClinical Study ReportPeer ReviewCross-Functional Teams

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Contribute to trial design under guidance using standard statistical methods
Draft and review protocols, statistical analysis plans (SAPs), and case report forms (CRFs) using templates and precedents
Perform or support statistical analyses according to statistical analysis plans, escalating issues when needed
Represent Biostatistics and PDD at the Study Team level and ensure statistical and scientific rigor of study deliverables under guidance
Collaborate with study team members to meet deliverables following existing processes
Summarize findings clearly with support from senior colleagues
Contribute to clinical study report (CSR) development and regulatory responses using established templates
Address moderately complex statistical or data issues and seek guidance for novel or ambiguous situations
Participate in peer review and mentoring relationships to uphold quality and build methodological and regulatory expertise

Requirements

What you’ll need

MSc or PhD in Statistics, Biostatistics, or a closely related quantitative field
0-2 years of relevant experience in clinical trial statistics within a pharmaceutical, biotech, or CRO setting
Familiarity with ICH guidelines, GCP, and regulatory requirements (e.g., FDA, EMA)
Strong understanding of statistical principles and methodology relevant to clinical trial design and analysis
Proficiency in SAS and/or R and familiarity with CDISC standards
Capacity for independent thinking and ability to make decisions based upon sound principles
Strategic agility, problem-solving, and critical thinking skills
Respect for cultural differences in a global workplace
Excellent verbal and written communication skills, specifically presentation and writing, with ability to explain complex technical concepts clearly
Preferred: experience working in cross-functional teams
Preferred: experience with multiple phases of drug development (early and/or late stage)