Lead Biostatistician II: Analysis, Study Design & CSRs

CTI Clinical Trial and Consulting Services; Covington (KY); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Generous health benefits

Vacation packages

Paid parental leave

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services is seeking a Lead Biostatistician to guide statistical activities across studies. You will serve as the primary statistical contact, develop analysis plans, and oversee SDTM/ADaM datasets and TLFs, while ensuring adherence to GCP/ICH guidelines.

Responsibilities include designing studies, performing analyses, and contributing to CSRs and regulatory submissions. The role requires a Master’s in biostatistics and hands-on experience in pharma/CRO

Qualifications

• 2 years of related biostatistics experience in pharma/CRO environments.
• 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.
• Experience explaining complex statistical concepts to project teams.
• BLA/NDA submission experience with regulatory communication.
• Therapeutic experience in transplantation, autoimmune diseases, and kidney and liver disease.

Responsibilities

• Act as primary statistical contact for internal and external project team members.
• Communicate and work with Biostatistics management to maintain project budgets and timelines.
• Review CRFs and completion instructions.
• Develop SDTM/ADaM datasets and TLFs to support analyses.
• Develop Interim Analysis Plans and SAPs per protocol as needed.
• Perform statistical analyses and validate programs per SOPs.
• Contribute to statistical reports and CSRs or publications.
• Assist in planning and designing clinical studies including power analysis, randomization, and protocol sections.

Skills

Biostatistics

Statistical analysis

Regulatory knowledge

Team communication

Explain complex stats

Education

Master's degree in Biostatistics or related

Tools

CDISC SDTM

ADaM

ICH/GCP guidelines

Job description

CTI Clinical Trial and Consulting Services is seeking a Lead Biostatistician to guide statistical activities across studies. You will serve as the primary statistical contact, develop analysis plans, and oversee SDTM/ADaM datasets and TLFs, while ensuring adherence to GCP/ICH guidelines.

Responsibilities include designing studies, performing analyses, and contributing to CSRs and regulatory submissions. The role requires a Master’s in biostatistics and hands-on experience in pharma/CRO