George Higginson is searching for an experienced Senior Biostatistician to work through an FSP model for their early Phase I and II projects. As the Lead Statistician, you will be spearheading the team, engaging in a wide range of interesting and challenging tasks, especially being the main point of contact through their Phase I-II studies.
Responsibilities of the role:
- Biostatistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design
- Review project database structures, edit checks, and data management coding conventions
- Preparation of statistical analysis plans (SAP) including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
- Statistical analysis, Interpretation of data and reporting of results
- Writing of the statistical methods sections of integrated study reports; reviews draft integrated study reports
- Supports responses to regulatory questions on the design of the program, and any labelling claims following submission
- Participates in presentations at client and investigator meetings
- Preparation of biostatistics input to research proposals, and participates in proposal defense meetings, and makes presentations at marketing meetings with prospective client
Requirements:
- M.S. or Ph.D. degree in statistics, biostatistics, or related field (required)
- 6+ years of relevant experience with M.S. OR 4+ years of relevant experience with Ph.D. (with at least 4-5 years of experience in the pharmaceutical industry)
- Excellent verbal and written communication skills
- In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas
- Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must
- Prior experience interacting with sponsor/clients
- Experience leading Phase I and/or Phase II studies
- Oncology experience is essential.
How To Apply
AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If youโre interested, please apply below. If this position doesnโt interest you, please visit our website for a list of more vacancies.
George Higginson
AL Solutions
Tel: +44 (0) 203 778 0909
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AL Solutions
Since its establishment in 2018, AL Solutions has experienced remarkable growth, specializing in the Life Science Industry
A global headhunting team supporting the Life Science industry across the UK, EU, USA.
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