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59 Seconds AgoSaved
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Remote
United States
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Senior level
Senior level
Pharmaceutical
The Clinical Quality Assurance Consultant provides GCP oversight, conducts audits, supports FDA inspection readiness, and collaborates with clinical operations for risk management in late-phase clinical trials.
Top Skills: Fda RegulationsIch-GcpRisk-Based Quality Management Principles
4 Days AgoSaved
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Remote
United States
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Senior level
Senior level
Pharmaceutical
The Principal Statistical Programmer Consultant leads programming for oncology trials, ensuring programming quality and regulatory compliance while collaborating with various teams and managing timelines.
Top Skills: Cdisc AdamCdisc SdtmRSAS
6 Days AgoSaved
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Remote
United States
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Senior level
Senior level
Pharmaceutical
Provide statistical leadership for oncology Phase I-III trials: develop SAPs/protocols/CSRs, design efficacy and safety analyses, oversee SDTM/ADaM datasets and TLFs, support interim/DMC and adaptive analyses, contribute to regulatory submissions, and mentor junior statisticians.
Top Skills: AdamCdiscRSASSdtm
7 Days AgoSaved
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Remote
United States
Easy Apply
Senior level
Senior level
Pharmaceutical
Lead statistical design and analysis for late-phase oncology studies, including protocol development, sample size, SAPs, oversight of data quality, tables/figures, mentoring statisticians, and coordinating project deliverables while ensuring regulatory compliance.
7 Days AgoSaved
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Remote
United States
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Senior level
Senior level
Pharmaceutical
Lead and support statistical programming deliverables for clinical studies: implement protocol programming, ensure high-quality outputs and documentation, write/implement specifications, enforce standards and compliance, contribute best practices, manage tasks, communicate risks, and collaborate with statisticians, data managers, and study leads.
Top Skills: Cdisc
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7 Days AgoSaved
Easy Apply
Remote
United States
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Senior level
Senior level
Pharmaceutical
Lead statistical strategy and deliverables for Immunology clinical trials. Author and review SAPs, ADS, and clinical study report sections; review analysis outputs; collaborate with Clinical, Programming, Data Management, and Regulatory teams; mentor programmers; ensure FDA/ICH/GCP compliance.
Top Skills: SAS
7 Days AgoSaved
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Remote
United States
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Senior level
Senior level
Pharmaceutical
Client-facing data scientist supporting clinical data transfer, ETL, validation, analysis, and Power BI dashboards. Build R scripts, assist data harmonization, support internal tools and basic web interfaces while working with cross-functional teams on clinical trial data.
Top Skills: CSSEdcETLHTMLJavaScriptMedrioPower BIPythonRRaveRelational DatabasesSASSQLVeeva
7 Days AgoSaved
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Remote
United States
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Senior level
Senior level
Pharmaceutical
Develop and validate SDTM and ADaM datasets using R following CDISC standards; support TLF generation, QC checks, regulatory deliverables, automation and R-based pipelines; collaborate with statisticians, data managers, and clinical teams.
Top Skills: AdamAdmiralCdiscGitGxp ValidationHavenPharmaverseRR MarkdownSASSdtmShinyTidycdiscTidyverse
7 Days AgoSaved
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Remote
United States
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Senior level
Senior level
Pharmaceutical
Lead statistical programming strategy and teams for clinical studies, oversee development/validation of SDTM/ADaM datasets and TLFs, ensure regulatory submission readiness (eCTD), drive SAS/R workflows, automation, and cross-functional collaboration with biostatistics, data management, and regulatory teams.
Top Skills: AdamCdiscEctdRSASSdtm
7 Days AgoSaved
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Remote
United States
Easy Apply
Senior level
Senior level
Pharmaceutical
Lead RWE study design and execution: develop protocols, statistical analysis plans, and R/SQL programs to produce analysis-ready datasets, tables, and figures; apply causal inference, time-to-event, and predictive methods; collaborate with scientists and stakeholders to deliver RWE insights.
Top Skills: Ai/MlClaimsDeep LearningEhrMachine LearningRSQL
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