SENIOR STATISTICIAN

Senior Statistician – Almirall Responsible for the statistical strategy to be applied across the different clinical trials within the clinical drug development of a product. Key Responsibilities Project related: Responsible for ensuring alignment in the statistical strategy across all the clinical trials within the same project. Collaboration in Statistical regulatory interactions with health authorities during clinical development process, and safety evaluation documents. Participation and Statistical support to the Project Team (PT), Strategic Clinical Team (SCT), Data Science Team (DS) and any other team as needed. Collaboration in the preparation of registration dossier (ie. integrated analysis plans, post hoc analyses, etc). Collaboration for defining the general strategy of Probability of Technical Success (PTS) calculations, need of consistency within each drug development. Responsible for standards of the Statistical analyses Data sets to ensure the FDA/Health authorities requirements. Collaborate in the creation of presentations for congresses and/or papers for medical journals, and lead or support discussions with external experts. Collaboration in preparing meetings with Health Authority meetings and Advisory Boards, Publications and other presentations. Trial related: Responsible for statistical support within a CT. Defining the statistical aspects of the design of the CT, stats methods and analyses. Responsible for all the statistical documents related to a CT (Synopsis, protocol, Statistical Analyses Plan (SAP), Tables Figures and Listings (TFLs)). Coordination and oversight of the CRO that will be in charge of performing the statistical analyses of the CT. Statistical support to other Departments within and beyond R&D (such as Data Management, Data Science, GMA, MA, Licensing in). Responsible for the PTS calculations to minimize the risk of conducting a non-successful trial. Interaction with the Partners (statisticians) to discuss different statistical aspects of new licensing opportunities. Coordination of all Post-Hoc analyses needed for knowledge generation and papers/publications. Non-project related: Continuing education and training on medical, clinical, and statistical research topics. Assistance to courses, congresses, trainings, investigator’s meetings, specialised journals reading, international conferences, etc. Continuing education on national and international policies for the development of CT. Participation in Almirall internal meetings. Statistical training to R&D. Company Purpose and Values We transform patients’ world by helping them realize their hopes & dreams for a healthy life. Our values: Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed. Courage: we challenge the status quo, we take full ownership and we learn from our success & failures. Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets. Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple. Seniority Level Mid-Senior level Employment Type Full-time Job Function Research and Science Industries Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr