About the Hiring GroupRTI International, is an independent nonprofit research institute dedicated to improving the human condition, is seeking a Senior Clinical Trial Statistician (Sr. Stat) who is a strategic and hands-on leader responsible for overseeing end-to-end analysis activities across multiple clinical trials. This role ensures the integrity, accuracy, and completeness of clinical trial data in compliance with Good Clinical Practice (GCP), regulatory guidelines, and company standard operating procedures (SOPs). The Sr. Stat serves as the primary liaison between internal teams, contract research organizations (CROs)/external vendors, providing oversight, guidance, and innovation in all aspects of statistical analysis. This role plays a critical part in accelerating timelines, supporting regulated clinical trials, and driving the overall success of clinical development programs.
What You'll DoStudy Leadership & Strategy- 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.
Data & Analysis Quality, Oversight & Delivery- 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.
Cross-Functional & Regulatory Support- 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.
CRO & Vendor Management- 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.
What You'll NeedEducation & Experience- Master's degree in Statistics, Data Science, Mathematics, or a related field and minimum of 6 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 8 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.
- 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.
- Vendor/CRO oversight experience.
- Technical proficiency in R is required. Additional proficiency in SAS, Python, or other data programming preferred.
- Demonstrated ability to work independently, exercise judgment, and drive outcomes with minimal supervision.
#LI-KV1
Hiring Salary Range$125,000 - $153,000
