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:
o Responsible for ensuring alignment in the statistical strategy across all the clinical trials within the same project.
o Collaboration in Statistical regulatory interactions with health authorities during clinical development process, and safety evaluation documents.
o Participation and Statistical support to the Project Team (PT), Strategic Clinical Team (SCT), Data Science Team (DS) and any other team as needed.
o Collaboration in the preparation of registration dossier (ie. integrated analysis plans, post hoc analyses, etc).
o Collaboration for defining the general strategy of Probability of Technical Success (PTS) calculations, need of consistency within each drug development.
o Responsible for standards of the Statistical analyses Data sets to ensure the FDA/Health authorities requirements.
o Collaborate in the creation of presentations for congresses and/or papers for medical journals, and lead or support discussions with external experts.
o Collaboration in preparing meetings with Health Authority meetings and Advisory Boards, Publications and other presentations.
* Trial related:
o Responsible for statistical support within a CT. Defining the statistical aspects of the design of the CT, stats methods and analyses.
o Responsible for all the statistical documents related to a CT (Synopsis, protocol, Statistical Analyses Plan (SAP), Tables Figures and Listings (TFLs)).
o Coordination and oversight of the CRO that will be in charge of performing the statistical analyses of the CT.
o Statistical support to other Departments within and beyond R&D (such as Data Management, Data Science, GMA, MA, Licensing in).
o Responsible for the PTS calculations to minimize the risk of conducting a non-successful trial.
o Interaction with the Partners (statisticians) to discuss different statistical aspects of new licensing opportunities.
o Coordination of all Post-Hoc analyses needed for knowledge generation and papers/publications.
* Non-project related:
o 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.
o Continuing education on national and international policies for the development of CT.
o Participation in Almirall internal meetings.
o 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
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