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F.F. Hoffmann-La Roche AG

Statistician(m/w/x)

Basel
Full-timeOn-siteExperienced

Clinical trial design and statistical analysis for life-changing medicines. MSc/PhD in Statistics and 2+ years in clinical trials required. SAS/R proficiency, familiarity with ICH/GCP.

Requirements

  • MSc or PhD in Statistics, Biostatistics, or related quantitative field
  • Minimum 2 years relevant experience in clinical trial statistics
  • Familiarity with ICH guidelines, GCP, and regulatory requirements
  • Strong understanding of statistical principles and methodology
  • Proficiency in SAS and/or R
  • Familiarity with CDISC standards
  • Capacity for independent thinking and decision-making
  • Excellent strategic agility, problem-solving, and critical thinking skills
  • Respect for cultural differences in global workplace interactions
  • Excellent verbal and written communication skills, presentation and writing
  • Ability to explain complex technical concepts in clear language
  • Experience working in cross-functional teams
  • Effective communication skills, translating complex statistical concepts
  • Experience with multiple phases of drug development
  • Excellent communication skills, influencing and translating complex data
  • Strategic mindset for portfolio-level decisions

Tasks

  • Contribute to trial design using standard statistical methods
  • Draft and review protocols, statistical analysis plans, and case report forms
  • Perform or support statistical analyses as per statistical analysis plans
  • Escalate issues when needed
  • Represent Biostatistics and PDD at the Study Team level
  • Ensure statistical and scientific rigor of study deliverables
  • Collaborate with study team members to meet deliverables
  • Summarize findings clearly with support from senior colleagues
  • Contribute to CSR development and regulatory responses
  • Address moderately complex statistical or data issues
  • Seek guidance for novel or ambiguous situations
  • Adhere to functional standards through peer review
  • Participate in mentoring relationships to build expertise

Work Experience

  • 2 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • SAS
  • R
  • CDISC standards
  • ICH guidelines
  • GCP
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