Remote Biostatistician II - Clinical Trials Lead

Ctifacts; Northern (KY); Remote; USD 110,000 - 140,000; Full time

Job summary

CTI Clinical Trial and Consulting Services is seeking a Biostatistician II with clinical trial experience to lead statistical activities remotely from the United States. You will manage study design, programming, and reporting tasks across CSRs and publications, ensuring compliance with ICH/GCP and CTI SOPs.

The role requires a Master’s in Biostatistics or related field and at least two years of pharma/CRO biostatistics experience, with SDTM/ADaM mapping and regulatory submission exposure.

Qualifications

• 2 years of related biostatistics experience in pharmaceutical or CRO environments.
• Ability to explain complex statistical concepts to project teams.
• BLA/NDA submission experience; regulatory representation.

Responsibilities

• Serve as lead Biostatistician for assigned studies.
• Act as primary statistical contact for internal and external project team members.
• Review CRFs and data collection instructions; assist in data cleaning.
• Develop IAPs and SAPs as required by protocol.
• Create SDTM/ADaM specifications and TLFs for analysis datasets.
• Program and validate statistical analyses per SOPs; prepare CSR sections.
• Assist in study design, endpoints, power/sample size, and randomization planning.

Skills

Biostatistics

CDISC SDTM/ADaM

ICH guidelines

Statistical programming

Communication of statistics

Education

Master’s degree in Biostatistics or related field

Job description

CTI Clinical Trial and Consulting Services is seeking a Biostatistician II with clinical trial experience to lead statistical activities remotely from the United States. You will manage study design, programming, and reporting tasks across CSRs and publications, ensuring compliance with ICH/GCP and CTI SOPs.

The role requires a Master’s in Biostatistics or related field and at least two years of pharma/CRO biostatistics experience, with SDTM/ADaM mapping and regulatory submission exposure.