Description:
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