A leading biopharmaceutical company is currently hiring a Contract Statistician to join their team in Switzerland. This company is committed to improving patient outcomes and quality of life in oncology and bacterial infections. This is an exciting opportunity to bring expertise and skills to an established and in-demand company that specialises in drug development, drug manufacturing and digital health investment.
- 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.
- Ensuring timely availability of complete, accurate and consistent analysis results to support decision making.
- Providing statistical input to the design, analysis and interpretation of clinical studies.
- Authoring statistical sections of protocols and statistical analysis plans.
- Ensuring provision of quality and timely statistical analyses results that support quality and timely decision making.
- Leading statistical and programming study teams and perform statistical analyses.
- Coordinating and provide statistical oversight for outsourced studies, ensuring CROs accountability for the quality of their deliverables.
- Representing statistics within cross functional study teams and provide statistical support and solutions.
- Assisting with in interactions with health Authorities.
- Maintaining current scientific and regulatory knowledge.
- Providing input/lead internal process improvement.
- Ensuring adherence to GCP, regulatory guidelines, standard processes and SOPs.
Skills and Requirements:
- MSc. or PhD in Mathematical 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.
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 contact Emma Adams at +44 203 854 3893 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 €70000.00 per annum
Rome (province), Italy
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