Statistician Italy

Permanent / Italy

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Statistician Italy

We are working with a global Pharmaceutical company who have built a fantastic reputation based on an unwavering focus on clinical development and an ethical approach. The company operated in the top echelons of the Pharma world and had continuously been recognised for its drug pipeline and for being a top employer.

Role

• Represent the statistics function in support of a clinical study.
• Provide statistical input to development and submission plans, and support of regulatory submissions.
• Provide accurate, statistically valid deliverables based on study protocols, statistical analysis plans for study reports or regulatory submission documents.
• Implement project level database (including derived database), analysis and reporting standards. Provide suggestions to achieve high quality databases and specifications by working with Data Management and Programming at study level.
• Plan, direct or self-implement study-level analysis and reporting activities including review of work from other programmers.
• Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
• Anticipate and communicate study level resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
• Support implementation of departmental standards and process improvements.

Requirements

• Experience with Phase I-IV clinical trials
• Experience with EMEA / FDA Regulatory requirements
• Experience with SAS programming
• Fluent English

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk. We regard all communication and correspondence as confidential. Full job descriptions are available on request.