Lead Biostatistician - Clinical Trials & SDTM/ADaM Expert

CTI; Lisboa; Hybrid; EUR 40,000 - 65,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Vacation packages

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services is seeking a Biostatistician II with clinical trial experience in Lisboa. You will serve as lead biostatistician on assigned studies, act as the primary statistical contact, and collaborate with management to manage budgets and timelines.

The role involves developing SAPs/IAPs, SDTM/ADaM datasets, TLFs, and contributing to CSRs and publications. Hybrid work arrangement and regulatory knowledge are required.

Qualifications

• Minimum 2 years of biostatistics experience in pharma or CRO.
• Master’s degree in Biostatistics or related field.
• CDISC SDTM and ADaM mapping experience.
• Knowledge of ICH guidelines and regulatory requirements.
• Ability to explain complex statistical concepts to teams.
• BLA/NDA submission experience.
• Therapeutic experience in transplantation, autoimmune diseases, and kidney/liver disease.

Responsibilities

• Act as primary statistical contact for internal and external project teams.
• Maintain project budgets and timelines with biostatistics management.
• Review CRFs and completion instructions.
• Develop SAPs and IAPs per protocol.
• Develop SDTM/ADaM datasets specifications and TLFs.
• Perform statistical analyses and validate programs.
• Contribute to statistical reports and CSRs.
• Assist in planning and designing clinical studies (design, power, randomization).

Skills

Biostatistics

Statistical analysis

Clinical trial experience

SDTM/ADaM

Regulatory knowledge

Communication

Budget & timelines management

Education

Master’s degree in Biostatistics, Statistics, or related field

Tools

CDISC SDTM/ADaM mapping

Job description

CTI Clinical Trial and Consulting Services is seeking a Biostatistician II with clinical trial experience in Lisboa. You will serve as lead biostatistician on assigned studies, act as the primary statistical contact, and collaborate with management to manage budgets and timelines.

The role involves developing SAPs/IAPs, SDTM/ADaM datasets, TLFs, and contributing to CSRs and publications. Hybrid work arrangement and regulatory knowledge are required.