Senior Biostatistician - Lead Studies & Mentor Team

CTI; Lisboa; Presencial; EUR 50 000 - 85 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work from home opportunities

Tuition reimbursement

Dedicated training department

Paid parental leave

Resumo da oferta

CTI Clinical Trial and Consulting Services in Lisbon seeks a Biostatistician with 4+ years of biostatistics experience in pharma or CRO to lead statistical tasks on studies and act as the primary contact for project teams.

You will design studies, review CRFs, develop SAPs/IAPs, perform analyses, mentor junior statisticians, and contribute to capability presentations while ensuring compliance with CTI SOPs.

Qualificações

• At least 4 years of related biostatistics experience in pharma or CRO.
• Master’s degree in Biostatistics, Statistics, or related field.
• CDISC, SDTM, and ADaM dataset mapping experience.
• BLA/NDA submission experience; regulatory representation preferred.
• Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology and rare disease preferred.
• Experience providing statistical consulting to internal/external clients preferred.

Responsabilidades

• Act as primary statistical contact for internal and external project teams.
• Manage projects to ensure statistics tasks align with the project timeline.
• Develop or review IAPs and SAPs as needed per protocol.
• Review CRFs and completion instructions.
• Develop or review SDTM/ADaM datasets, TLFs, and related outputs.
• Perform statistical analyses and validate programs per SOPs.
• Plan and design clinical studies including power analysis and randomization procedures.
• Ensure timely, quality deliverables according to CTI SOPs and ICH/GCP guidelines.
• Maintain records and contribute to departmental meetings.

Conhecimentos

Biostatistics experience

Statistical consulting

Project management

Regulatory communication

Formação académica

Master’s degree in Biostatistics

Ferramentas

CDISC

SDTM

ADaM

Descrição da oferta de emprego

CTI Clinical Trial and Consulting Services in Lisbon seeks a Biostatistician with 4+ years of biostatistics experience in pharma or CRO to lead statistical tasks on studies and act as the primary contact for project teams.

You will design studies, review CRFs, develop SAPs/IAPs, perform analyses, mentor junior statisticians, and contribute to capability presentations while ensuring compliance with CTI SOPs.