Principal Biostatistician | AL Solutions | Remote (Italy)
Job Description
George Higginson is searching for an experienced Biostatistician for one of the leading Oncology specialist Biotech’s. As a Principal Biostatistician, you will be part of a top firm who have extensive knowledge of Biometrics as well as having grown by 150% across Europe over the past 24 months. This fantastic success of their Phase 2 Oncology trials, growth plans have been set in place, to assist the Biometrics Function required from this Principal Biostatistician.
Responsibilities of the role:
- Biostatistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomisation 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 5+ years of relevant experience with a Ph.D.
- 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
- Experience leading studies.
- MUST be fluent in Italian.
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 you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.
George Higginson
AL Solutions
Tel: +44 (0) 203 778 0909