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Position Summary

Responsible for the statistical strategy to be applied acros 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.

Corporate:

• English fluent.
• Statistics / Mathematics / Data Science
• Communication and Negotiation skills
• Previous Experience in the role

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