Experteer Overview As part of Almirall’s clinical drug development team, you will lead the statistical strategy across all trials within a project, ensuring consistency and regulatory readiness. You will partner with cross-functional teams to shape analyses, documentation, and technical success metrics, while engaging with health authorities. The role blends design, analysis, and communication to support registrations and knowledge generation. You’ll contribute to a patient‑centered mission by enabling robust, timely decisions.Compensaciones / Beneficios
- Align statistical strategy across all clinical trials within a project
- Collaborate on regulatory interactions with health authorities during development and safety evaluations
- Provide statistical support to Project Team, Strategic Clinical Team, Data Science Team and others
- Contribute to registration dossier preparations (integrated analysis plans, post hoc analyses)
- Define strategy for Probability of Technical Success (PTS) calculations and ensure consistency across development
- Ensure statistical analysis datasets meet FDA/Health Authority requirements
- Assist in creating presentations for congresses/papers and engage external experts
- Prepare meetings with Health Authorities and Advisory Boards, publications and other presentations
- Oversee statistics-related design, SAPs, TFLs and related documents for each clinical trial
- Coordinate CROs responsible for statistical analyses
- Support other departments (Data Management, Data Science, GMA, MA, Licensing)
- Coordinate and perform post-hoc analyses for knowledge generation
- Pursue ongoing education in medical, clinical and statistical topics
- Support R&D statistical training and internal initiativesResponsabilidades
- unknownRequisitos principales
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