Lead Biostatistician - CDISC SDTM/ADaM Expert (Hybrid)

Ctifacts; Lisboa; Híbrido; EUR 65 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work from home opportunities

Tuition reimbursement

Paid parental leave

Health benefits

Vacation package

Resumo da oferta

CTI Clinical Trial and Consulting Services is seeking a Lead Biostatistician to oversee statistical activities across studies. You will act as the primary statistical contact, manage timelines, and ensure data quality from CRFs to final reports.

Required are 4+ years in biostatistics, a Master’s in Biostatistics, and CDISC mapping experience. The role offers a hybrid work model with opportunities for mentoring and career development.

Qualificações

• 4+ years of related biostatistics experience in pharmaceutical or CRO environments.
• Experience providing statistical consulting to internal/external clients.
• Regulatory submission experience (BLA/NDA) preferred.

Responsabilidades

• Act as primary statistical contact for internal and external project team members.
• Manage projects to ensure statistics tasks are performed within the project timeline.
• Review CRFs and completion instructions; provide data design input.
• Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs).
• Develop or review SDTM and ADaM dataset specifications and mock tables/listings/figures (TLFs).
• Perform statistical analyses by programming derived datasets and TLFs and validate colleagues’ programs.
• Review programming of team members and contribute to statistical reports and CSRs.
• Plan and design clinical studies including design, endpoints, power analysis and randomization procedures.
• Develop or review Randomization Plans and randomization programs/lists.
• Ensure activities comply with CTI SOPs and GCP/ICH guidelines and maintain eTMF records.

Conhecimentos

Biostatistics experience

Programming & data analysis

Formação académica

Master’s degree in Biostatistics

Ferramentas

CDISC SDTM ADaM mapping

Descrição da oferta de emprego

CTI Clinical Trial and Consulting Services is seeking a Lead Biostatistician to oversee statistical activities across studies. You will act as the primary statistical contact, manage timelines, and ensure data quality from CRFs to final reports.

Required are 4+ years in biostatistics, a Master’s in Biostatistics, and CDISC mapping experience. The role offers a hybrid work model with opportunities for mentoring and career development.