Lead Biostatistician, RWE & Study Leadership (Hybrid)

Cti Clinical Trial And Consulting Services; Almada; On-site; EUR 80,000 - 134,000; Full time

Job summary

CTI Clinical Trial and Consulting Services is seeking a Senior Biostatistician to lead statistical activities across studies. You will act as the primary statistical contact, manage timelines, and guide CRF design, data management, and programming for analyses.

Requirements include 4+ years in biostatistics in pharma/CRO, a Master’s in Biostatistics, and CDISC/SDTM/ADaM experience. Regulatory submission experience is a plus, with opportunities in a global CRO setting.

Qualifications

• At least 4 years of related biostatistics experience in pharma or CRO environments.
• 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 diseases preferred.
• Experience providing statistical consulting to internal/external clients.

Responsibilities

• 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.
• Identify and communicate changes in scope to the clinical project manager and Biostatistics management.
• Review CRFs and completion instructions.
• Give input to database design and data edit considerations.
• Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs).
• Develop or review SDTM/ADaM specifications and TLFs for analyses.
• Perform statistical analyses and validate programs according to SOPs.
• Review programming of other team members.
• Develop or review statistical methods and results sections of reports and CSRs.
• Plan and design clinical studies including randomization/blinding procedures.
• Carry out activities per GCP/ICH guidelines.

Skills

Biostatistics experience

Statistical consulting

BLA/NDA submission experience

Education

Master's degree in Biostatistics

Tools

CDISC

SDTM

ADaM

Job description

CTI Clinical Trial and Consulting Services is seeking a Senior Biostatistician to lead statistical activities across studies. You will act as the primary statistical contact, manage timelines, and guide CRF design, data management, and programming for analyses.

Requirements include 4+ years in biostatistics in pharma/CRO, a Master’s in Biostatistics, and CDISC/SDTM/ADaM experience. Regulatory submission experience is a plus, with opportunities in a global CRO setting.