Lead Clinical Statistician
hace 1 mes
La misión principal será construir y liderar equipos de estadísticos y representantes de otras funciones y asegura el uso de métodos de análisis estadístico apropiados y eficientes durante el desarrollo, presentación y/o gestión del ciclo de vida de los productos de nuestro cliente según los estándares, procedimientos y pautas regulatorias globales y regionales aplicables, y representa proyectos ante la dirección y los comités de gobierno.
Funciones
- Responsable del plan completo de desarrollo clínico.
- Simulación de resultados de ensayos clínicos utilizando SAS o R.
- Lidera equipos (virtuales) interfuncionales de estadísticos, analistas estadísticos y especialistas en integración de datos.
- Contribuye al desarrollo y evolución de estándares del proyecto.
- Brinda consultoría estadística y metodológica y contribuye a equipos multidisciplinarios dentro o entre empresas, produciendo el plan completo de análisis estadístico y guiando a los programadores con las especificaciones necesarias para el análisis.
- Responsable de la producción y precisión de los análisis estadísticos e interpretación de los resultados.
- Responde a consultas de autoridades sanitarias y otros socios internos o externos.
- Influye en los procesos de toma de decisiones durante el desarrollo de medicamentos y/o la gestión del ciclo de vida mediante el uso de metodología estadística apropiada (por ejemplo, simulaciones, metaanálisis o enfoques de modelado).
- Doctorado o Máster Bioestadística, Estadística o Matemáticas.
- Al menos cuatro años de experiencia como estadístico con tiempo significativo dedicado en la Industria Farmacéutica, Biotecnología o sector similar.
- Conocimiento exhaustivo de la industria farmacéutica, incluida la comprensión del proceso de desarrollo clínico de medicamentos y/o la gestión del ciclo de vida y los documentos y regulaciones asociados.
- Experiencia en liderar equipos.
- Experiencia en múltiples campos relevantes para su subfunción estadística.
- Buen conocimiento de lenguajes de programación estadística (incluido SAS principalmente y R secundariamente).
- Es un plus tener experiencia en realización de metaanálisis y metaanálisis de red es
- Fluidez en inglés.
- Buenas habilidades comunicativas.
- Alta capacidad de trabajo en equipo y colaborativa, así como también de forma independiente.
- Alta capacidad analítica.
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