Mathematician

Your responsibilities

Responsibilities as Biostatistician (m/f/d) in the business area of (Clinical) Assay Development and Life Cycle Management:

• Meet highest standards in qualifications and validations of assays aligned with guidelines. In particular, assure compliance of statistical methodology and its implementation.
• Prioritize and take responsibility of the implementation of tasks and statistical deliverables within the assigned assay projects in close collaboration with the responsible scientist.
• Contribute to the statistical performance of the full Assay-Statistics and -Programming team as required, including self-reliant and -organized programming and reporting.
• Support decision-making to take place within the parameters set by logical, quantitative scientific inference.
• Generate state-of-the-art assay development plans and reports from set-up to validation including input to assay target profiles and stability monitoring plans in close collaboration with scientists.
• Provide arguments for statistical positions/approaches internally (e.g. governance) as well as externally (e.g. customer).
• Deliver quality and timely release of all statistical deliverables for all projects of the assigned assays. This includes analysis plans, statistical programs as well as reports.
• Communicate and present effectively (in English) within the statistical team and with scientists up to senior level.
• Enjoy intercultural and interdisciplinary teamwork with the ability to understand and simplify complex situations and to explain technical issues to customers or non-technical audience.

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Requirements and needed knowledge:

• Minimum Level of Education: University degree (e.g. Bachelor or Master) in Statistics or Mathematics or equivalent
• Area of Specialization: Statistics with related programming skills (e.g. SAS, R, JMP)
• Experience as statistician, preferably in pharmaceutical industry, with proven ability to work in international multidisciplinary teams
• Work experience with proven programming skills to manage data as well as to implement and produce statistical analyses
• Knowledge of and experience in project management as well as (pre-)clinical research or development and related practices and guidelines would be a real benefit