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Position Summary
Responsible for the statistical strategy to be applied across the different clinical trials within the clinical drug development of a product.
Core 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.
Experience
* Over 4 years of experience in the pharmaceutical industry.
Specific Expertise
Role Specific
* Participation in clinical trials.
* Basic knowledge of adaptive designs and Bayesian statistics.
* Familiarity with machine learning applied to clinical data.
* Strong teamwork and cross‑functional collaboration skills.
* Fluent in English (spoken and written).
* Knowledge in Statistics, Mathematics, and Data Science.
* Excellent communication and negotiation skills.
Corporate
* English fluent.
* Statistics, Mathematics, Data Science.
* Communication and negotiation skills.
* Previous experience in the role.
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