Clinical Data Analyst/Statistician at Santhera Pharmaceuticals
Date de publication :
18 février 2025Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Pratteln
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Résumé de l'emploi
Santhera Pharmaceuticals est une entreprise suisse spécialisée dans le traitement des maladies neuromusculaires rares. Rejoignez-nous pour améliorer la vie des patients.
Tâches
- Diriger l'équipe de biostatistiques et assurer l'expertise statistique.
- Définir les méthodes statistiques pour le développement des médicaments.
- Participer aux interactions avec les autorités réglementaires.
Compétences
- Diplôme de M.Sc. en statistiques ou sciences de la vie exigé.
- Expertise dans la conception d'études cliniques et analyse statistique.
- Compétences en communication et maîtrise de l'anglais requises.
Résumé de l'annonce originale
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Head Biostatistics
Location: Pratteln, Switzerland (Hybrid) Scope of Work
As Head of Biostatistics you will lead the Biostatistics team, provide the Statistical and Data expertise to the Program Team and ensure adequate implementation of statistical methodology to the Santhera's drug development program, including clinical development, global registration of the product, market access, medical marketing and life-cycle management. This role currently reports to the Head of Development. Key Responsibilities
- Ensures that appropriate statistical methodology is used in the assigned Santhera's development program.
- Provides line management to the Biostatistics team such as statisticians, statistical programmers and data management.
- Acts as Program Statistician in the Global Program Team.
- Define appropriate outsourcing strategy for biostats activities and ensure appropriate oversight.
- Reviews/approves study-level essential documents (e.g. clinical study protocols, statistical analysis plans, clinical study reports) and project-level documents (e.g. clinical development plans, target product profiles).
- Provides input to the regulatory strategy for global regulatory submissions.
- Participates in global meetings & interactions with regulatory authorities as an expert statistician role.
- Provides input/reviews relevant sections of global regulatory submissions, e.g. documents in Module 2 of the dossiers.
- Develops processes and standard operating procedures related to statistical programming and statistics.
- Works in a matrix function with the development and commercial teams.
- M.Sc. degree or higher in statistics or life sciences.
- At least 10 years' professional experience as clinical data analyst/statistician in a pharmaceutical company or CRO.
- Minimum 5 years of people management experience.
- Experience in designing global pivotal programs.
- Experience in global regulatory interactions.
- Experience in supporting market access, medical marketing and life-cycle management of products.
- Expertise in designing clinical studies, authoring statistical sections of clinical trial protocols, authoring statistical analysis plans, reviewing and providing statistical feedback and interpretation for clinical study reports, authoring and reviewing regulatory documents, e.g. briefing books.
- Thorough understanding of statistical methods typically used in clinical development and ability to implement novel methodologies.
- Outstanding level of written and spoken English.
- Good communication skills.
