Reference: 210 07/01/2022 11:24:37

Biostatistics Coordinator.

Milan - Italy Depending on experience

Immediate Start ** Italy ** Home Based 

The Biostatistics Coordinator will take the lead on a range of clinical projects and coordinate/delegate workload to the wider team. You will be a Senior or Principal Statistician with excellent planning and organisational skills.

Duties and Specific Tasks:

  • Collaborate with the Head of Biostatistics in coordinating and supervising the activities of the Statistical team.
  • Ensure processes are correctly applied within the Statistical team.
  • Liase with the study team, sponsors and external stakeholders regarding statistical activities, study design and results of statistical analyses.
  • Collaborate with the Head of Biostatistics in defining the timeframes and costs of each project and preparing the biddings and invoices for the sponsor.
  • Collaborate in establishing and maintaining document/programming standards.
  • Can act as senior biostatistician in case of specific projects.
  • Collaborate with the Head of Biostatistics to establish and maintain SOPs related to the Biostatistics unit.
  • Monitor updates in regulations and statistical methodology in clinical research applicable to company activities and support related implementations. 
  • Present and share knowledge at team meetings.
  • Organise/perform trainings for project team and acts as a mentor for junior staff.
  • Contribute to hiring and on-boarding of new associates.

Work and Education Minimum Requirements:

  • Master Degree in Statistics (or equivalent degree) with a specialisation in medical or epidemiological statistics. 
  • At least 3 years of experience in CRO, biotech, pharma, research institutes or similar.
  • Proven knowledge and expertise in statistics and its applications to clinical research.
  • Solid knowledge and experience in drug development process and GCP guidelines.
  • Solid knowledge of SAS and other statistical software packages.
  • Experience in developing CDISC standard specifications and datasets (SDTM, ADaM).
  • Knowledge of computer systems related to clinical trials (EDC, IVRS, IWRDS, EPRO, CTMS, etc.).
  • Project Management and problem-solving skills.
  • Excellent communication and team-working skills.
  • Strong commitment to quality.
  • Proactive attitude and independence in organising activities.
  • Flexibility and propensity for innovation.
  • English fluent.
  • Planning and organisational skills.
  • Leadership and communication skills.
  • Result-oriented.
  • Team-working oriented.

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Emily Bradbury
Emily Bradbury
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