Dear AllStat
Our client is a rapidly expanding pharmaceutical group located in Switzerland, its strategy focuses on the development and registration of innovative pharmaceutical products. An exciting opportunity has arisen within the Research & Development Division for an experienced;
Statistician/Data Manager
Main Responsibilities:
Plan, define and monitor statistics and data management activities of company-sponsored phase 1 to 4 clinical trials;
Contribute to the evaluation and preparation of clinical development programs including preparation of clinical trials protocols in conjunction with other internal functions and external providers;
Contribute to the preparation of function-specific strategies and documents such as statistical analysis plans, data validation plans, CRFs design, data cleaning, database structure, etc;
Technically evaluate the results of clinical trials and contribute to the preparation of the ICSRs;
Interact with external service providers such as CROs and consultants;
Represent the function in interdisciplinary project teams.
Education/Experience Requirements:
University Degree (MS level or higher) in Mathematical Sciences/Statistics;
5+ years of international experience in a similar role;
Thorough understanding of ICH and area-specific guidelines;
SAS programming skills;
Experience with CDISC standards;
Working knowledge of ancillary areas such as clinical operations, regulatory affairs, etc.;
Proficiency in written and spoken English and possibly Italian;
Excellent communication and writing skills;
Ability to handle and prioritize multiple assignments in a fast-paced environment;
Demonstrated ability to work in teams;
International travel experience.
For further details please contact me directly at [log in to unmask]
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