DescriptionWhy RTIRTI International is an independent, scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solutions in pursuit of a better future. Clients rely on us to answer questions that demand an objective and multidisciplinary approachโone that integrates expertise across social, statistical, data, and laboratory sciences, engineering, and other technical disciplines to solve the worldโs most challenging problems.We believe in the promise of science and technical solutions, and we push ourselves every day to deliver on that promise for the good of people, communities, and businesses in the US and around the world. If you are looking for the opportunity to make a real difference, RTI is the place for you. 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 DoKey Responsibilities Study Leadership & StrategyAct 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 clientsโ needs into statistical practice.Data & Analysis Quality, Oversight & DeliveryCollaborates 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 SupportRoutinely 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 ManagementProvide 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 & ExperienceMasterโs 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 Bachelorโs 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. Additional proficiency in SAS, Python, or other data programming preferred.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 Stated and should not require, now or in the future, sponsorship for employment visa status (e.g., H-1B visa status, etc).#LI-KV1 EEO & Pay Equity StatementsFor San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here. RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. For Applicants in Massachusetts Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include 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, and numerous other offerings to support a healthy work-life balance. Equal Pay Act Minimum/Range$138,000 - $169,000
ResponsibilitiesKey Responsibilities Study Leadership & StrategyAct 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 clientsโ needs into statistical practice.Data & Analysis Quality, Oversight & DeliveryCollaborates 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 SupportRoutinely 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 ManagementProvide 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
QualificationEducation & ExperienceMasterโs 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 Bachelorโs 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. Additional proficiency in SAS, Python, or other data programming preferred.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 Stated and should not require, now or in the future, sponsorship for employment visa status (e.g., H-1B visa status, etc).#LI-KV1