Sr Integrated Analyses Statistician

hace 1 mes


Madrid, Madrid, España Morgan Philips Executive Search A tiempo completo
Nuestro cliente es una empresa multinacional biotecnológica, y estamos buscando para Barcelona un Estadístico Analista Senior.

La misión principal será proporciona de manera independiente experiencia estadística a equipos interfuncionales, lidera equipos de estadísticos y programadores, y asegura el uso de métodos de análisis estadístico apropiados y eficientes durante el desarrollo, presentación y/o gestión del ciclo de vida de acuerdo con los estándares, procedimientos y pautas regulatorias globales y regionales aplicables..

Funciones
  • Responsable del plan completo de desarrollo clínico.
  • Proporcionar aportes estadísticos a los Equipos de Proyecto Clínico para diseñar, planificar y llevar a cabo análisis post-hoc de bases de datos de ensayos clínicos existentes y metaanálisis para la evaluación de eficacia, seguridad y beneficio-riesgo.
  • Desarrollar planes estadísticos maestros globales para resúmenes integrados (por ejemplo, para presentaciones a agencias reguladoras).
  • Generar publicaciones, presentaciones y pósters basados en análisis integrados en colaboración con los Equipos de Proyecto Clínico.
  • Liderar equipos interfuncionales de estadísticos, analistas estadísticos y especialistas en integración de datos.
  • Apoyar la estandarización de las estructuras de bases de datos e implementar procesos estándar para análisis integrados.
  • Responsabilidad de la producción y precisión del análisis estadístico e interpretación de los resultados.
  • Orientar y colaborar con Organizaciones de Investigación por Contrato para garantizar que el trabajo estadístico externalizado esté alineado con los estándares de datos, análisis y calidad establecidos y los plazos.
Requisitos
  • Doctorado o Máster en Bioestadística, Estadística o Matemáticas
  • Al menos dos años de experiencia como estadístico con un tiempo significativo en la industria farmacéutica, biotecnológica o sector similar
  • Buen conocimiento de lenguajes de programación estadística (incluidos SAS y/o R)
  • Conocimiento en la realización de metaanálisis y metaanálisis de red es ventajoso
  • Conocimiento en marcos cualitativos de beneficio-riesgo (B-R) (FDA/EMA) y experiencia en la aplicación de métodos cuantitativos de evaluación de B-R es favorable
  • Inglés fluido
Skills
  • Buenas habilidades comunicativas.
  • Fuertes habilidades de comunicación y capacidad para trabajar tanto de forma independiente como colaborativa


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