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IQVIA is a publicly-traded healthcare intelligence company founded in 2016 upon the merger of two market leaders: Quintiles and IMS Health. With locations aroun
Principal Biostatistician FSP - Early Phase Clinical Development (PK)
Location
United States + 1 moreAll locations: United States | Canada
Posted
102 days ago
Salary
$126K - $235K / year
Seniority
Lead
No structured requirement data.
Job Description
Principal Biostatistician FSP - Early Phase Clinical Development (PK)
IQVIA
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Le biostatisticien principal est responsable du soutien statistique apporté aux programmes de développement de médicaments en phases précoces, en particulier pour les études chez des sujets sains avec des critères d’évaluation PK et PD. Qualifications - Doctorat en statistiques, biostatistiques ou domaine connexe, avec au moins 3 ans d'expérience dans l'industrie pharmaceutique. - Maîtrise en statistiques, biostatistiques ou domaine connexe, avec au moins 5 ans d'expérience dans l'industrie pharmaceutique. - Au moins 2 ans d'expérience en analyse statistique des critères d'évaluation PK non compartimentaux dans l'industrie pharmaceutique. - Connaissance des BPC de l'ICH, des directives réglementaires relatives aux études de pharmacologie clinique et des pratiques/normes de l'industrie. - Expérience avec CDISC, notamment SDTM, ADaM et CDASH. - Capacité démontrée à travailler de manière autonome en gestion de projet et en prise de décision. - Capacité à communiquer efficacement ses idées et à encadrer les programmeurs de manière constructive. - Maîtrise de SAS pour effectuer des analyses et valider des données importantes. Requirements - Collaborer avec des équipes de projet multidisciplinaires pour établir les échéanciers. - Contribuer à l'analyse statistique des synopsis et protocoles d'études. - Rédiger les sections statistiques des protocoles d'essais cliniques, notamment le calcul de la taille des échantillons, en collaboration avec des experts internes et externes. - Examiner les eCRF et autres documents de gestion des données. - Créer ou examiner les randomisations et les spécifications associées. - Rédiger ou examiner les plans d'analyse statistique, les spécifications des ensembles de données et les spécifications TLF. - Encadrer et superviser les programmeurs dans la rédaction des spécifications des ensembles de données d'analyse et la programmation des tableaux, listes et figures. - Assurer l'examen et la validation statistiques de ces éléments. - Utiliser SAS et/ou R pour effectuer des analyses inférentielles et valider les principales dérivations de données. - Interpréter les résultats des études et vérifier l'exactitude des rapports de résultats. - Assurer le suivi des activités des projets internes et des CRO, notamment les échéanciers, les livrables et la disponibilité des ressources. - Collaborer avec les équipes de gestion des données, de développement clinique et de pharmacologie clinique/PK en apportant une expertise statistique. - Contribuer à la rédaction des rapports d'études cliniques et autres documents réglementaires (DSUR, IB, etc.). - Fournir du soutien aux analyses exploratoires. - Posséder du soutien aux activités liées aux demandes d'autorisation d'essais cliniques (IND). Benefits - Possibilités de télétravail. - Équilibre travail-vie personnelle et horaires flexibles. - Collaborer avec des équipes de recherche et de statistiques motivées et performantes. - Formation technique et programme de développement personnalisé. - Possibilités de recherche qui correspondent à vos compétences uniques. - Parcours de carrière prometteur. - Stabilité d'emploi : contrats à long terme et possibilités de redéploiement. - Priorité à la commercialisation de nouvelles thérapies plutôt qu'aux budgets et aux avenants. - Environnement de travail stimulant et dynamique. - Bon équilibre travail-vie personnelle.
Job Requirements
- Doctorat en statistiques, biostatistiques ou domaine connexe, avec au moins 3 ans d'expérience dans l'industrie pharmaceutique.
- Maîtrise en statistiques, biostatistiques ou domaine connexe, avec au moins 5 ans d'expérience dans l'industrie pharmaceutique.
- Au moins 2 ans d'expérience en analyse statistique des critères d'évaluation PK non compartimentaux dans l'industrie pharmaceutique.
- Connaissance des BPC de l'ICH, des directives réglementaires relatives aux études de pharmacologie clinique et des pratiques/normes de l'industrie.
- Expérience avec CDISC, notamment SDTM, ADaM et CDASH.
- Capacité démontrée à travailler de manière autonome en gestion de projet et en prise de décision.
- Capacité à communiquer efficacement ses idées et à encadrer les programmeurs de manière constructive.
- Maîtrise de SAS pour effectuer des analyses et valider des données importantes.
- Collaborer avec des équipes de projet multidisciplinaires pour établir les échéanciers.
- Contribuer à l'analyse statistique des synopsis et protocoles d'études.
- Rédiger les sections statistiques des protocoles d'essais cliniques, notamment le calcul de la taille des échantillons, en collaboration avec des experts internes et externes.
- Examiner les eCRF et autres documents de gestion des données.
- Créer ou examiner les randomisations et les spécifications associées.
- Rédiger ou examiner les plans d'analyse statistique, les spécifications des ensembles de données et les spécifications TLF.
- Encadrer et superviser les programmeurs dans la rédaction des spécifications des ensembles de données d'analyse et la programmation des tableaux, listes et figures.
- Assurer l'examen et la validation statistiques de ces éléments.
- Utiliser SAS et/ou R pour effectuer des analyses inférentielles et valider les principales dérivations de données.
- Interpréter les résultats des études et vérifier l'exactitude des rapports de résultats.
- Assurer le suivi des activités des projets internes et des CRO, notamment les échéanciers, les livrables et la disponibilité des ressources.
- Collaborer avec les équipes de gestion des données, de développement clinique et de pharmacologie clinique/PK en apportant une expertise statistique.
- Contribuer à la rédaction des rapports d'études cliniques et autres documents réglementaires (DSUR, IB, etc.).
- Fournir du soutien aux analyses exploratoires.
- Posséder du soutien aux activités liées aux demandes d'autorisation d'essais cliniques (IND).
Benefits
- Possibilités de télétravail.
- Équilibre travail-vie personnelle et horaires flexibles.
- Collaborer avec des équipes de recherche et de statistiques motivées et performantes.
- Formation technique et programme de développement personnalisé.
- Possibilités de recherche qui correspondent à vos compétences uniques.
- Parcours de carrière prometteur.
- Stabilité d'emploi : contrats à long terme et possibilités de redéploiement.
- Priorité à la commercialisation de nouvelles thérapies plutôt qu'aux budgets et aux avenants.
- Environnement de travail stimulant et dynamique.
- Bon équilibre travail-vie personnelle.
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