Biostatistics Manager
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ProClincial is working with a global medical technology company that is seeking a Biostatistics Manager to be based in London on a permanent basis.
Job Responsibilties:
- Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.
- Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.
- Contributes to or prepares statistical analysis plans.
- Collaborates with Data management, Clinical Development, and Clinical Operations on design of eCRFs.
- Provides statistical guidance on conduct of ongoing trials.
- Collaborates with Statistical Programmers on summary and analysis of trial data. Writes ADS and ad hoc analysis specifications.
- Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
- Contributes to scientific articles, summarizing data collected in clinical trials.
- Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
- Consults with Research & Preclinical colleagues on statistical questions in their work.
- Manages CRO statistical and programming support.
Skills and Requirements:
- PhD in Biostatistics, Statistics, or Equivalent with at least 3 years pharmaceutical biostatistics experience or MS with at least 5 years of relevant experience. Title will be commensurate with experience
- Excellent written and oral communication and presentation skills.
- Experience programming in SAS.
- Experience with simulations
- Understanding of ICH GCP as well as general knowledge of industry practices and standards.
- Familiarity with R programming language and other statistical software, including EAST.
- Experience with CDISC, including SDTM, ADaM, CDASH.
To Apply:
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.
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