ID EXISTS
POS 2893
Status 5
DJM 1

Senior Biostatistician

Beschreibung: For one of our German Biotech clients we are seeking freelance support as: Senior Biostatistician (M/F/D)
Tasks:
  • Provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with leading edge knowledge and overall product strategy
  • Lead the development of the statistical analysis plan for clinical trials
  • Provide specifications and directions to the statistical programmers in establishing 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 to ensure quality of deliverables
  • Represent Biostatistics in meetings with cross-functional project teams ensuring adherence to FDA/ICH guidelines, Good Clinical Practices, and regulatory requirements
Qualification:
  • Start: asap, latest April / 6 months + / 4-5 days per week
  • Masters or PhD in the field of Medical Biometry with 2-5 years industry experience
  • Comprehensive knowledge of statistical methodology in design, analysis and regulatory requirements relating to clinical development of drugs
  • Prior involvement in submission activities (EU or US)
  • Familiarity with complex statistical methods that apply to Phase I-IV clinical trials
  • Expertise in designing clinical trials, including the development of study related documents
  • Knowledge of statistical software “Base SAS”, “SAS Macros”, “Addplan” and “R”
  • Extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines
  • Expertise in medical research, especially oncology and inflammatory diseases
  • Must Have: Business fluency in English
  • Nice to have: German
Bemerkungen: WANTED: Senior Biostatistician (M/F/D). Please contact +49 89 18 90 998 44 or lisa.model@k-recruiting.com

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Skills: 21 CFR Part 11 (Electronic records, electronic signatures), Biostatistics / Statistics, English, FDA (USA: Food and Drug Administration), German, SAS Programmer
Interesse geweckt?
Auf geht's!
Beginn: Asap, latest April
Laufzeit: 6 months +
Einsatzort: Greater Area Munich
WhatsApp-Service: Mit WhatsApp zum nächsten Projekt!

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