ID EXISTS
POS 3221
Status 1
DJM 1

Senior Biostatistician

Beschreibung: For one of our German Biotech clients we are seeking freelance support as: Senior Biostatistician (M/W/D)
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Tasks:
  • Generate input to clinical development plans, clinical study reports and regulatory submission materials
  • Support and develop the statistical analysis plan for clinical trials
  • Establish standards for clinical conduct and data collection, management and/or reporting
  • Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results
  • Provide guidelines and standards to CROs
  • Represent the Biostatistics department in meetings with cross-functional project teams
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Qualification:
  • Masters or PhD in the field of Medical Biometry
  • Up to 5 years industry experience
  • Profound knowledge of statistical methodology in design and regulatory requirements relating to clinical development
  • Experience in submission activities
  • Knowledge of statistical methods (Phase I-IV clinical trials)
  • Expertise in designing clinical trials
  • Knowledge of statistical software “Base SAS”, “SAS Macros”, “Addplan” and “R”
  • Extensive knowledge of ICH guidelines, 21 CFR Part 11, and FDA guidelines
  • Must Have: Business Fluency in English
  • Nice to Have: German
Bemerkungen: WANTED: Senior Biostatistician (M/F/D). Please contact +49 89 18 90 998 35 or christian.braumueller@k-recruiting.com Skills: Biostatistics / Statistics, English, German, Pharma
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 6 months
Einsatzort: Bavaria
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