RTI International · 1 day ago
Senior Clinical Trial Statistician
United States
Full-time
Remote
Senior Level, Lead/Staff
$138K/yr - $169K/yr
10+ years expRTI International is an independent, scientific research institute dedicated to improving the human condition. They are seeking a Senior Clinical Trial Statistician who will oversee end-to-end analysis activities across multiple clinical trials, ensuring data integrity and compliance with regulatory guidelines. This role involves collaboration with various teams and managing statistical analysis to support clinical development programs.
ConsultingEducationGovernmentNon Profit
No H1B
Hiring Manager
Kelly Vester
Responsibilities
Act as the lead trial statistician and provide the associated expertise for assigned Phase II/III trials, ensuring timely delivery of high-quality, submission-ready analyses
In collaboration with trial coordinators, investigators, and data managers, provide strategic input into study designs, sample size calculations, protocol development and implementation, data collection strategies, and analytic plans to optimize trial quality and efficiency
Ability to oversee and perform work to author, maintain, and implement study-level statistical analysis plans, analysis dataset specifications and TLF shells, randomization approaches, analysis and reporting programs, and other analysis-related deliverables and activities
Drive continuous alignment of analysis strategy with overall program milestones and regulatory objectives
Ability to translate clients’ needs into statistical practice
Collaborates with data management to ensure accuracy, consistency, and completeness of trial data through ongoing review, cleaning, and reconciliation (SAE, labs, imaging, biomarkers, PK, PRO/ePRO, etc.)
Ability to oversee and perform work to support operational reporting (e.g., sponsor/leadership status reports, DSMB reports, operational support reports)
Coordinate and oversee interim and final analyses, collaborating on timing of database snapshots and ensuring data and analysis integrity for study monitoring, publications, and regulatory filings
Champion and help design and implement risk-based monitoring (RBQM) and centralized data review
Ability to oversee and perform work involved in adoption of CDISC standards (SDTM/ADaM) in analysis dataset creation
Routinely collaborate and liaise with Clinical Operations, Programming, Data Management, Medical Monitoring, and Safety throughout trial development and implementation to ensure alignment of analytic deliverables with trial and submission objectives
In collaboration with Clinical Operations and Data Management, design and develop data driven clinical trial surveillance reports to ensure quality of data at the trial and site level
In collaboration with Clinical Operations and Data Management, ensure data collection, completion and cleaning occurs per expected timelines and support escalation and resolution of identified issues
Collaborate with Clinical Operations, Data Managers, and Medical Monitors in pharmacovigilance data management and regulatory reporting
Deliver high-quality analytic results, datasets, listings, and reports to support regulatory submissions and health authority inspections
Collaborate on clinical study reports (CSRs), publications, and scientific presentations, ensuring analytic interpretation accuracy and consistency
Provide oversight, governance, and quality management of CRO analytic deliverables, holding vendors accountable to timelines, budget, and quality
Review and approve vendor specifications and resulting deliverables
Proactively identify and escalate risks, implementing corrective actions to ensure successful partnership and delivery
Qualification
Required
Master's degree in Statistics, Data Science, Mathematics, or a related field and minimum of 10 years of progressive experience in clinical trial analysis within a biotech, pharmaceutical, or CRO environment for trials conducted under INDs or equivalent experience
Equivalent experience is defined as a Bachelor's degree and 12 years of experience
Proven track record of leading statistical aspects of Phase II/III clinical trials through development, database lock, and reporting/submission
Deep understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements, including expertise in design/analysis, CDISC standards (SDTM, ADaM), and associated electronic data submission to regulatory agencies
Technical proficiency in R is required
Vendor/CRO oversight experience
Strong leadership and project management skills, with the ability to manage multiple priorities in fast-paced environments
Exceptional problem-solving and analytical ability, with a focus on data integrity and risk management
Skilled communicator, able to influence and collaborate across cross-functional teams and with external partners
Able to lead meetings with both internal and external collaborators and communicate complex statistical concepts to both researchers and lay audiences
Demonstrated ability to work independently, exercise judgment, and drive outcomes with minimal supervision
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status (e.g., H-1B visa status, etc)
Preferred
Additional proficiency in SAS, Python, or other data programming preferred
Benefits
A competitive base salary
A generous paid time off policy
Merit based annual increases
Bonus opportunities
A robust recognition program
A competitive range of insurance plans (including health, dental, life, and short-term and long-term disability)
Access to a retirement savings program such as a 401(k) plan
Paid parental leave for all parents
Financial assistance with adoption expenses or infertility treatments
Financial reimbursement for education and developmental opportunities
An employee assistance program
Numerous other offerings to support a healthy work-life balance
Company
RTI International
RTI is an independent, nonprofit institute that provides research, development, and technical services to government and commercial clients.
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
$18.06MKey Investors
US Department of EnergyU.S. Environmental Protection AgencyAscendium Education Group
2024-09-17Grant· $0.8M
2023-10-23Grant· $0.5M
2023-04-13Grant· $10M
Leadership Team
Michael H. Kaelin Jr.
EVP & Chief Operating Officer
Linda Dimitropoulos
Sr. Director, Primary Data Collection, Data & Analytics Practice Area
Recent News
2025-12-02
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2025-10-20
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