Statistical Scientist (f/m)

Einsatzort: Marburg

Driven by Our Promise

CSL Behring is one of the world's leading manufacturers and providers of innovative, life-saving pharmaceuticals made from human plasma as well as related treatments. The company has approximately 20,000 employees globally, of which there are about 2,800 in Germany at the largest production and research location of CSL Behring in Marburg.

People who work for CSL Behring are committed to saving the lives of patients throughout the world. This involves top performance, as we strive to be the best. For our Global Clinical Development department we are looking for a

Statistical Scientist (f/m)

R-060673

The Statistical Scientist provides components of statistical contribution to a clinical development program. The Statistician implements statistical strategies for the clinical trials and regulatory submissions, and is accountable for the statistical deliverables.

Main Responsibilities and Accountabilities

  • Support biostatistics to conduct study data collection, data analysis, reporting, and submission preparation
  • Be accountable for timely completion and quality of the statistical analysis plan. Manage outsourcing operations within the responsible projects. Ensure timeliness and quality of deliverables by CRO
  • Conduct reviews of deliverables to ensure quality. Support biostatistics interactions with authorities (eg, FDA, EMA, PMDA) Be responsible for result accuracy in study report and regulatory submission documents
  • Perform quality control of the CDISC deliverables
  • Conduct ad hoc statistical analyses
  • Support improvement initiatives and related standards for infrastructure / process / scientific consulting

Qualifications / experience

  • PhD or MS in Biostatistics, Statistics, or related fields
  • 3 years of experience in clinical development in a pharmaceutical or biotechnology setting
  • Statistical support in facilitating and optimizing clinical development programs
  • Support to regulatory submissions desired
  • Experience managing CRO preferred
  • Advanced knowledge and training in applications of statistical methodologies
  • Basic knowledge of clinical development and processes
  • Ability to collaboratively work and provide leadership in matrix environment
  • Strong interpersonal and communication skills (verbal and written in English)
  • Proficient in SAS programming
  • Desired expertise in
    • Statistical methodologies
    • CDISC, statistical programming, and/or data standards
    • Biostatistics and Statistical Programming Operations