Sr Integrated Analyses Statistician
hace 1 mes
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.
- 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
- Buenas habilidades comunicativas.
- Fuertes habilidades de comunicación y capacidad para trabajar tanto de forma independiente como colaborativa
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