ProClinical is working with a swiss-headquartered global pharmaceutical company that is seeking a Biostatistician to be based in Geneva on a permanent basis. The Statistician provides statistical support and input to the design and analysis of clinical studies. Is accountable for the quality and timelines of all statistical and programming deliverables for assigned clinical studies, including studies for which statistical activities are outsourced to CRO partners. He/she ensures timely availability of complete, accurate and consistent analysis results to support decision making. He/she is a key member of the clinical study team.
- Provide statistical input to the design, analysis and interpretation of clinical studies
- Author statistical sections of protocols and statistical analysis plans
- Ensure provision of quality and timely statistical analyses results that support quality and timely decision making
- Lead statistical and programming study teams and perform statistical analyses
- Coordinate and provide statistical oversight for outsourced studies, ensuring CROs accountability for the quality of their deliverables
- Represent statistics within cross functional study teams and provide statistical support and solutions
- Assist with in interactions with health Authorities
- Maintain current scientific and regulatory knowledge
- Provide input/lead internal process improvement
- Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs.
Skills and Requirements:
- MSc. or PhD in statistics or related field
- Minimum of 4 years' experience as project/study statistician in Clinical Development in the pharmaceutical industry or CRO
- Strong statistical methodology knowledge and applications. Experience using Bayesian designs is a plus
- Excellent programming skill in SAS. Experience using R is a plus
- Good experience using CDISC standards
- Up to date knowledge of regulatory requirements related to statistics
- Good communication skills and ability to build positive relationships
- Fluent in English
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Walker on +44 203 8569 336 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Up to Swiss Franc195000 per annum
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