Lead Biostatistician — Clinical Trials (Hybrid)

CTI; Covington (KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Tuition reimbursement

Health benefits and paid vacation

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services seeks a Lead Biostatistician to guide studies, serve as primary statistical contact, and develop IAPs/SAPs, SDTM/ADaM datasets, and TLFs for analysis. You will contribute to RSS, CSRs, and publications with strong regulatory awareness.

The role requires 2+ years in pharma/CRO biostatistics, a Master’s degree, CDISC SDTM/ADaM experience, and ICH/GCP compliance. CTI offers hybrid work arrangements, competitive benefits, and a global collaboration

Qualifications

• 2 years of related biostatistics experience in pharma or CRO
• Master’s degree in Biostatistics, Statistics, or related field
• CDISC SDTM and ADaM mapping experience; regulatory knowledge

Responsibilities

• Serve as primary statistical contact for internal and external project team members
• Communicate and maintain project budgets and timelines with Biostatistics management
• Review case report forms (CRFs) and completion instructions
• Develop SDTM/ADaM dataset specifications and mock tables/figures (TLFs)
• Perform statistical analyses by programming derived datasets and TLFs and validate programs
• Develop/review statistical methods and results sections of reports, CSRs, or publications
• Assist in planning/designing clinical studies (design, endpoints, sample size, randomization)
• Follow CTI SOPs and GCP/ICH guidelines; maintain accurate records in eTMF

Skills

Biostatistics experience

Regulatory submissions experience

Communication of statistics

Education

Master’s degree in Biostatistics or related field

Tools

CDISC SDTM/ADaM mapping

Job description

CTI Clinical Trial and Consulting Services seeks a Lead Biostatistician to guide studies, serve as primary statistical contact, and develop IAPs/SAPs, SDTM/ADaM datasets, and TLFs for analysis. You will contribute to RSS, CSRs, and publications with strong regulatory awareness.

The role requires 2+ years in pharma/CRO biostatistics, a Master’s degree, CDISC SDTM/ADaM experience, and ICH/GCP compliance. CTI offers hybrid work arrangements, competitive benefits, and a global collaboration