Senior Biostatistician, Clinical Trial Experience Required

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🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Assist with development and modification of department SOPs and work instructions • Train new Biostatistics employees and mentor junior Biostatisticians • Develop study bids and scope changes for prospective client RFPs • Present Biostatistics study execution tasks at capabilities presentations • Serve as primary statistical contact for internal and external project team members • Manage Biostatistics tasks within project timelines and communicate timeline changes • Identify and communicate changes in scope • Review case report forms and completion instructions • Provide input on database design and data-edit considerations • Develop or review Interim Analysis Plans and Statistical Analysis Plans • Develop or review SDTM and ADaM dataset specifications and mock tables, listings, and figures • Independently program derived datasets and TLFs and validate corresponding programs • Review programming by other team members • Develop or review statistical methods and results sections for reports, CSRs, and publications • Plan and design clinical studies, including endpoints, power analysis, randomization, blinding, and protocol statistical methods • Develop or review Randomization Plans and randomization programs or lists • Perform activities according to CTI SOPs, project conventions, GCP, and ICH guidelines • Maintain accurate work records and file statistics documents in the eTMF • Participate in departmental meetings

🎯 Requirements

• At least 4 years of related biostatistics experience in a pharmaceutical, CRO, or related statistical environment • Master’s degree in Biostatistics, Statistics, or a related field • CDISC, SDTM, and ADaM dataset mapping experience • BLA/NDA submission experience preferred • Regulatory representation experience preferred, including meeting preparation/attendance and regulatory communication follow-up • Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology, and rare disease preferred • Experience providing statistical consulting to internal/external clients preferred • Ability to work within Good Clinical Practice and International Conference on Harmonization guidelines • Knowledge of biostatistics SOPs and project-specific conventions • Ability to independently program derived datasets and TLFs and validate programs • Experience with Interim Analysis Plans, Statistical Analysis Plans, Randomization Plans, SDTM, ADaM, and clinical study reports

🏖️ Benefits

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