Biostatistician

Position summary

In this role you will directly participate in studies of novel anti-cancer drugs in small international team of biotechnology company.

You will directly participate in studies of novel drugs/therapies for cancer in biotechnology company.

Main Responsibilities:

  • Provide support and statistical expertise in set-up of the study (study design, sample size calculation, randomization setting, writing of statistical part of the protocol, cooperation with CDM in building of the database).
  • Write Statistical Analysis Plan (SAP).
  • Program statistical analyses, generate tables, figures and listings in SAS and create report.
  • Prepare presentation of the study results and cooperate with clinical team on interpretation of the study results.
  • Cooperate with medical writer in preparation of Clinical Study Reports (CSR) and review CSR from statistical perspective.
  • Compliance with agreed timelines.

Requirements:

  • Experience as biostatistician of clinical trials (experience in clinical trials in oncology or in early phases of clinical drug development)
  • Master degree in (Bio-)Statistics/ Mathematics (graduated or in last years of studies)
  • Experience with SAS programming (data handling, analysis, reporting)
  • Skills to provide suggestion for solution of unexpected situations via data handling or analysis.
  • Pro-actively thinking person.
  • Knowledge of environment of clinical trials including a must to follow guidelines, necessity to make a proper documentation related to statistical analysis, validation and reporting of the outputs, and to keep compliance with timelines. Knowledge on ICH and FDA guidelines.
  • Skills to work independently and cooperate with Clinical Data Management (CDM) and clinical team.
  • Fluent communication in English.

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