Biostatistician II, Clinical Trial Experience Required

🔥 1 minute ago

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Serve as the lead Biostatistician on assigned studies • Act as primary statistical contact for internal and external project team members • Work with Biostatistics management to maintain project budgets and timelines • Review case report forms and completion instructions • Provide input on database design and data edit considerations • Develop or assist with Interim Analysis Plans and Statistical Analysis Plans • Develop SDTM and ADaM dataset specifications and mock tables, listings, and figures • Independently program derived datasets and statistical tables, listings, and figures • Validate corresponding developer programs according to department SOPs • Develop or review statistical methods and results sections for statistical reports, clinical study reports, and publications • Assist with clinical study planning and design, including study design, endpoints, power analysis, sample size estimation, randomization, blinding, and protocol statistical methods • Develop or assist with Randomization Plans and randomization programs or lists • Perform activities according to CTI SOPs, project conventions, and GCP/ICH guidelines • Ensure timely, standardized, and high-quality deliverables • Maintain accurate work records and file relevant statistics documents in the eTMF

🎯 Requirements

• 2 years of related biostatistics experience in a pharmaceutical or CRO environment or other relatable statistical experience • 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 • Ability to explain complex statistical concepts to other project team members • BLA/NDA submission experience • Regulatory representation, including meeting preparation/attendance and follow-up with regulatory communication • Therapeutic experience in transplantation, autoimmune diseases, and kidney and liver disease • Clinical trial experience • Ability to work according to Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines • Ability to use biostatistics SOPs and maintain accurate project records • Ability to file statistics documents in the eTMF according to project-specific plans

🏖️ Benefits

• Structured mentoring program • Leadership courses • Tuition reimbursement • Ongoing education and training • Dedicated training department • Generous health benefits • Vacation packages • Hybrid work from home opportunities • Paid parental leave • CTI Cares program • Work-life balance support