Biostatistician II, Clinical Trial Experience Required

CTI Clinical Trial and Consulting Services

. Serve as the lead Biostatistician on assigned studies .

Posted 10/6/2026full-timeRemote • Kentucky • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Biostatistics with a strong focus on developing and validating statistical analysis plans, datasets, and reports while adhering to regulatory guidelines. Proficient in managing project timelines and budgets, ensuring high-quality deliverables in clinical trial settings.

Highest-signal resume keywords

Biostatistics ExperienceCDISC SDTM And ADaM MappingRegulatory RepresentationClinical Trial ExperienceMaster’s Degree In Biostatistics

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical Analysis PlansInterim Analysis PlansDerived Datasets ProgrammingStatistical Tables DevelopmentRandomization PlansPower AnalysisSample Size EstimationStatistical Methods DevelopmentDatabase Design InputCase Report Form Review

Soft Skills

Complex Concept ExplanationTeam Collaboration

Tools & Technologies

ETMFSOPs

Industry Keywords

Good Clinical Practice (GCP)International Conference On Harmonization (ICH)BLA/NDA SubmissionTransplantationAutoimmune DiseasesKidney DiseaseLiver Disease

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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