Lead Biostatistician for Clinical Studies & Analyses

CTI Clinical Trial and Consulting Services; Lisboa; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Tuition reimbursement

Paid parental leave

Health benefits

Job summary

CTI Clinical Trial and Consulting Services is seeking a Lead Biostatistician in Lisbon to manage statistical activities for complex studies. You will liaise with project teams, review data collection plans, and drive analysis plans in alignment with ICH, GCP, and CTI SOPs.

The role requires a Master’s in Biostatistics or related field, 2+ years of pharma/CRO biostatistics experience, and expertise in SDTM/ADaM mapping, study design, and regulatory submissions.

Qualifications

• 2 years of related biostatistics experience in pharmaceutical or CRO environment.
• Master’s degree in Biostatistics, Statistics, or related field.
• CDISC SDTM and ADaM dataset mapping experience.
• Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities.
• Experience explaining complex statistical concepts to project teams.
• BLA/NDA submission experience with regulatory interactions.
• Therapeutic experience in transplantation, autoimmune diseases, and kidney/liver disease.

Responsibilities

• Lead the Biostatistician on assigned studies and serve as primary statistical contact.
• Coordinate with Biostatistics management on project budgets and timelines.
• Review CRFs and data completion instructions.
• Contribute to database design and data cleaning considerations.
• Develop IAPs and SAPs as needed per protocol.
• Create SDTM/ADaM specifications and TLFs for analysis.
• Perform statistical analyses and validate programs per SOPs.
• Write/statistical methods for reports and CSRs.
• Assist in study design, power calculations, randomization plans, and protocol methods.
• Ensure compliance with GCP/ICH guidelines and CTI SOPs.
• Maintain accurate documentation in the eTMF per project plans.

Skills

Biostatistics experience

CDISC SDTM/ADaM mapping

ICH guidelines knowledge

Regulatory communication ability

BLA/NDA submission experience

Therapeutic experience (transplant/kid

Education

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

Job description

CTI Clinical Trial and Consulting Services is seeking a Lead Biostatistician in Lisbon to manage statistical activities for complex studies. You will liaise with project teams, review data collection plans, and drive analysis plans in alignment with ICH, GCP, and CTI SOPs.

The role requires a Master’s in Biostatistics or related field, 2+ years of pharma/CRO biostatistics experience, and expertise in SDTM/ADaM mapping, study design, and regulatory submissions.