Senior Biostatistician & Study Lead

CTI Clinical Trial and Consulting Services; Lisboa; Híbrido; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work from home

Health benefits

Tuition reimbursement

Resumo da oferta

CTI Clinical Trial and Consulting Services seeks an experienced Biostatistician to lead statistical activities on multiple studies. You will act as primary statistical contact, oversee analysis plans, and supervise programming of derived datasets and TLFs per GCP/ICH guidelines.

You will design studies, review CSR sections, and mentor junior statisticians. A Master’s in Biostatistics and 4+ years of experience are required; CTI offers hybrid work and strong career growth.

Qualificações

• 4+ years of biostatistics experience in pharma or CRO environment.
• Experience providing statistical consulting to internal/external clients.
• CDISC, SDTM, and ADaM mapping experience.

Responsabilidades

• Act as primary statistical contact for internal and external project team members.
• Manage projects to ensure statistics tasks are performed within the entire project timeline.
• Proactively identify and communicate changes in scope to the clinical project manager and Biostatistics management.
• Review case report forms (CRFs) and completion instructions.
• Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs).
• Develop or review SDTM and ADaM dataset specifications and mock tables, listings, and figures (TLFs).
• Perform the statistical analysis by programming derived datasets and TLFs and validating programs.
• Review programming of other team members.
• Develop or review statistical methods and results sections of reports or CSR.
• Plan and design clinical studies, including overall design, endpoints, power analysis, and randomization procedures.

Conhecimentos

Biostatistics experience

Statistical consulting

Mentoring and training

Formação académica

Master’s degree in Biostatistics or related field

Ferramentas

CDISC SDTM ADaM mapping

BLA/NDA submission experience

Descrição da oferta de emprego

CTI Clinical Trial and Consulting Services seeks an experienced Biostatistician to lead statistical activities on multiple studies. You will act as primary statistical contact, oversee analysis plans, and supervise programming of derived datasets and TLFs per GCP/ICH guidelines.

You will design studies, review CSR sections, and mentor junior statisticians. A Master’s in Biostatistics and 4+ years of experience are required; CTI offers hybrid work and strong career growth.