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.
- Team-working oriented.
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