Senior Statistical Programmer en CLINIPACE

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Senior Statistical Programmer

Fecha de la oferta: 11 Oct.
Empresa que publica esta oferta: CLINIPACE
Ver todas sus ofertas de empleo (2)
Número de vacantes: 1
Provincia/s: Madrid


Descripción: Job Duties and Responsibilities:
•Development and documentation of programs used in the production of computer-generated outputs for clinical study reports, registration and submission documents, publication requirements plus any other document used to present clinical trials data, e.g. answers to requests from health authorities, individual sponsors requests, scientific papers and conferences, etc. in line with existing regulatory guidelines, industry standards and standard operating procedures issued by Clinipace and/or clients as appropriate.
•Conception and generation of dataset specifications
•Design of integrated databases and development of mapping specifications for integrated datasets
•Development and documentation of programs used to generate datasets
•Development and documentation of programs used to generate listings, tables and graphs
•Program validation including generation of validation documentation
•Data preparation and documentation according to CDISC data standards
•Preparation of electronic submission of clinical data
•Providing internal consultancy in various review activities like database design, data validation rules, analysis plans, table shells etc.
•Design, development, documentation and validation of tools and macros to continuously improve the quality and efficiency of processes applied
•Coordination of allocated teams of Statistical Programmers assigned to a specific client project including the monitoring of workload, estimation and forecast of resource needs within the specific activity and responsibility for coaching
Tipo de contrato: Indefinido
Observaciones: Skills/Competencies
• Highly developed analytical skills, team player qualities (knowledge, skills, personal qualities)
• Fluency in English
• Expert knowledge in SAS
• Knowledge of relevant regulatory requirements
• Knowledge of medical terminology and conduct and analysis of clinical trials
• Knowledge of different indications of clinical trials
• Knowledge of industry data standards (e.g. CDISC SDTM and ADaM)

• Team player: Shows support for teamwork, cooperation, self-control, and flexibility to get the job done.
• Comfortable working under supervision and as part of a team.
• Practices professionalism and integrity in all actions.
• Demonstrates honesty, trust and fairness.
• Strong written and verbal communication skills

Job Location: Spain – office based in Madrid or home based (Any Spain location)


Requisitos: Job Requirements:
Education: BSc, MSc or equivalent experience in information technology, mathematics or statistics

• Minimum of 5 years of experience in processing and analyzing clinical trial data or a demonstrated aptitude for statistical programming work
• > 3 years practical experience in the use of a statistical software package (like SAS or R) with respect to all aspects of software development and validation
Nivel de estudios mínimo requerido: Diplomado
Idiomas requeridos: Inglés nivel Alto.
Experiencia profesional mínima requerida: 5 años
Disponibilidad para viajar requerida: Ninguna

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