Principal Biostatistician

George Higginson is searching for an experienced Principal Biostatistician for one of the market-leading CRO’s. As the Lead Biostatistician, you will be spearheading the team, engaging in a wide range of interesting and challenging tasks, especially being the main point of contact for their sponsors and vendors through their Phase I-III Oncology studies. This role is a split of 60% project management and 40% hands-on, technical work.

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)
• 9+ years of relevant experience with M.S. OR 7+ years of relevant experience with Ph.D. (with at least 6-8 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 II and/or Phase III 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 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

george@alsolutions.co.uk

Last updated on May 28, 2024