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CSL Behring
7d ago

Senior Biostatistician(m/w/x)

Glattbrugg
Full-timeOn-siteSenior
Data Science

Description

In this role, you will drive the statistical strategy for clinical trials, ensuring high-quality data analysis and regulatory compliance while overseeing critical deliverables from start to finish.

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Requirements

  • PhD or MS in Biostatistics, Statistics, or related field
  • PhD with 3 years drug development experience or comparable
  • MS with 6 years drug development experience
  • Advanced knowledge of clinical development statistical methodologies
  • Effective collaboration and leadership in matrix environments
  • Strong interpersonal and English communication skills
  • Proficiency in SAS and/or R
  • Familiarity with relevant regulatory guidance documents
  • Knowledge of CDISC, statistical programming, or data standards
  • Biostatistics and Statistical Programming Operations knowledge

Education

Doctoral / PhD
OR
Master's degree

Tasks

  • Lead statistical contributions for clinical development programs
  • Implement statistical strategies for clinical trials
  • Apply methodologies to study design and analysis
  • Support data collection and submission preparation
  • Ensure quality of Statistical Analysis Plans
  • Manage interactions with regulatory authorities
  • Interpret analysis results for accurate reporting
  • Oversee outsourced statistical activities and CRO deliverables
  • Manage preparation of TFLs and CDISC packages
  • Contribute to continuous improvement and process standards

Tools & Technologies

SASRCDISC

Languages

EnglishBusiness Fluent

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