Senior Biostatistician en CLINIPACE

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Senior Biostatistician

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

Descripción

Descripción: Job Duties and Responsibilities:
•Coordinate and approve Statistical Analysis Plans (SAP), mock-up tables, programming and derived dataset specifications developed by Biostatistics and Statistical Programming staff.
•Lead protocol development work including experimental design, randomization, sample size calculation, statistical methods, defining study objectives and parameters.
•Coordinate and approve the statistical section of the Clinical Study Report (CSR) written by Biostatistics staff, and collaborate with Medical Writer in preparing the integrated CSR as needed.
•Coordinate and approve TFL and derived datasets, programming of derived datasets and Tables, Figures and Listings (TFL), and data review and statistical analysis developed by Biostatistics and Statistical Programming staff.
•Provide management of other Biostatistics Department requirements and functions, such as SOP updates, as requested by line manager.
•Serve as Quality Control Biostatistician for sample size calculation reports.
•Serve as IDMC / DSMB statistician as needed.
•Other duties commensurate with the position as assigned by line manager.
•Provide staff training and study oversight as requested by line manager.
•Provide staff oversight as mutually agreed with line manager.
Tipo de contrato: Indefinido
Observaciones: • Skills/Competencies
o Interpersonal and communication skills.
o Ability to develop professional presentations for presenting statistical issues and solutions to clients internally.
o Ability to effectively learn and handle new or unfamiliar statistical methods.
o Ability to find needed written resources and interact with other Biostat staff with the needed familiarity.
o Willingness to share expertise with younger staff members.

•Capabilities
o Excellent broad ranging understanding of statistical methods and issues.
o Has a developed expertise in 1-2 therapeutic areas.
o Ensures statistical quality.
o Deep working knowledge of clinical drug development process.
o Has completed GCP training and has strong knowledge of ICH guidelines and other regulatory guidelines related to statistics.
o Develops capability for interacting with regulatory agencies on behalf of sponsor matters.
o Ability to serve as a Project Manager.
o Excellent training and presentation skills.
o Support the Business Development process through RFP process, bid defenses, attendance at scientific meetings, etc.

Job Location: Office based in Madrid, Spain or Home Based (Any Spain location)

Requisitos

Requisitos: Job Requirements
•Education: PhD or Master’s in statistics or related area, or equivalent degree globally
•Experience: PhD + 3-5 years (or MS + 5-7 years) experience in pharmaceutical, CRO, or related environment.
Nivel de estudios mínimo requerido: Licenciado
Idiomas requeridos: Inglés nivel Alto.
Experiencia profesional mínima requerida: 4 años
Disponibilidad para viajar requerida: Ninguna

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