My client is an industry renowned Italian Market Leader that have exciting projects within Oncology, Immunology, Inflammatory, Ophthalmology and Orphan Diseases. With a successful past, they are looking to further expand, their Italian team, to ensure a successful future.
If you are interested in taking on more responsibility, if you are interested in developing skills that will enable you to progress within your career, if you are interested in being involved deeper within the clinical development process, then this could be the right career choice for you.
The Statistician, under the supervision of the Head of Biostatistics, is in charge of the following activities:
- Be responsible for all statistical tasks on the assigned clinical trials, e.g. clinical trial design, sample size estimation, analysis plan, analysis populations, reporting activities, exploratory analyses
- Review the study objectives and endpoints with the Sponsor’s representative
- Generate the randomization list and collaborate with the Data Manager to produce the corresponding validation documents, and perform the acceptance tests
- Collaborate with the Data Management team in finalizing and developing the eCRF
- Write a detailed statistical analysis plan
- Develop programs or collaborate with the SAS programmer to generate analysis datasets/tables/figures/listings for clinical trials and/publications
- Write the Statistical Report and/or the statistical sections of the ICH Clinical Study Report
- Master’s Degree in Statistics (or equivalent degree)
- Demonstrable experience
- Good knowledge of English
- Strong planning and organizational skills