Senior Biostatistician en Linical - Pharma Resourcing Solutions (PRS)

Senior Biostatistician
Linical - Pharma Resourcing Solutions (PRS) | (2) ofertas activas
Linical- Global CRO cuenta con 24 años en España y alrededor de 800 empleados, siendo España el segundo país en cuanto a volumen de profesionales especializados. Servicios de Investigación Clínica son: Puesta en marcha y Monitorización de EECC, Gestión de Datos, Estadística, Redacción Científica, FV, Auditoría y Diseño de e-CRDs en proyectos de investigación clínica Fases I -IV y en Estudios de Post Comercialización con y sin fármaco -Observacionales, Epidemiología y Farmacoeconomía. Asimismo, la división de Pharma Resourcing Solutions (Linical-PRS) está especializada en selección y contratación de perfiles para la Industria Farmacéutica en los Departamentos Médicos y de Operaciones Clínicas
Madrid, 29 Jun.
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Descripción
Job Description
• Provides leadership and guidance to the Biostatistics team (e.g. Biostatistician, SAS Programmer) to ensure quality from biostatistics stand point
• Main point of contact for sponsor
• To be responsible for all aspects of statistical input for the design, analysis and reporting of allocated projects according to contracted services in compliance with current legislation, ICH Guidelines and appropriate company/Sponsor procedures and quality standards
• Participates within the Biostatistics team for completion of all biostatistics tasks to ensure that they are completed to required quality within the timelines for allocated projects according to contracted services
• Active participation in communications with other project teams, principally with the project manager
• Ensures that all biostatistics tasks has been carried out per appropriate validation program standards
• Review and/or input to study protocol, CRF, database design and validation specifications
• Preparation of the Statistical Analysis Plan, including template tables, listings and figures, in accordance with Linical SOPs, Sponsor specifications and Industry Guidelines
• Perform and/or supervise programming of tables, listings, figures, derived datasets and statistical analyses according to agreed timelines and quality standards
• Quality control of statistical output produced by other members of the department, including tables, listings, figures, derived datasets and statistical analyses
• Computes sample size calculations

Numero de vacantes: 1
Tipo de contrato: Indefinido
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Requisitos
Qualifications
• It is expected that for this role a minimum of 4 years’ previous experience of the design and analysis of clinical trials, including programming in SAS, is required.
• Extensive knowledge of the drug development process and experience interacting with regulatory authorities may be required.
• Disciplined Work Approach, Communication, Leadership, Problem Solving, Attention to Detail, Computer Skills, Language Skills.

Estudios mínimos
Licenciado
Idiomas
Inglés nivel Alto.
Experiencia mínima
3 años
Disponibilidad para viajar
Ninguna



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