Develop, validate, and maintain SDTM and ADaM datasets using R while ensuring compliance with CDISC standards. Collaborate with biostatistics and clinical teams to support clinical trial deliverables and automated reporting pipelines.
The Senior Scientist, Project Coordinator oversees the execution of medical affairs projects by managing timelines, budgets, and cross-functional teams. They serve as the primary point of contact for stakeholders while ensuring strategic alignment and risk mitigation throughout the project lifecycle.
Manage 2-3 clinical trials including site start-up, monitoring, and closeout activities. Conduct on-site and remote monitoring while ensuring data quality and regulatory compliance.
The consultant will lead the development and execution of statistical analysis plans for large-scale real-world evidence studies while providing strategic insights to stakeholders. They are also responsible for mentoring junior analysts and driving the implementation of advanced analytics and automated workflows.
The role involves authoring and reviewing aggregate safety reports for medicinal products, medical devices, and cosmetics to ensure regulatory compliance. Additionally, the lead will coordinate with stakeholders, manage signal detection activities, and provide functional guidance to junior team members.
The consultant will serve as a study statistician for infectious disease programs, overseeing protocol development, study design, and statistical analysis plans. They are responsible for ensuring the accuracy, validity, and quality of statistical outputs and reports throughout the clinical trial process.
The consultant will serve as a study statistician for infectious disease programs, responsible for protocol development, study design, and statistical analysis plans. They will provide statistical oversight to ensure data accuracy, consistency, and the validity of analysis across clinical studies.
The Principal Statistical Programmer will participate in CRF design, data validation, and the production of data listings, summary tables, and graphics for clinical trials. They will also coordinate data transfers with vendors and collaborate with biometrics functions to support ad-hoc requests and regulatory submissions.
The Senior Statistical Programmer Consultant supports clinical study programming deliveries by implementing protocol requirements and ensuring high-quality technical output. They also contribute to best practices, oversee documentation, and collaborate with cross-functional teams including statisticians and data managers.
Develop, validate, and maintain SDTM and ADaM datasets using R and SAS following CDISC standards. Collaborate with biostatistics and clinical data teams to support clinical trial deliverables and ensure regulatory compliance.
Drive revenue growth by securing new clients and expanding services for global clinical operations. Manage the full sales lifecycle from prospecting and relationship building to closing complex, high-value deals.
Lead statistical activities for clinical trials, primarily in Immunology, by overseeing strategy and deliverables. This includes authoring Statistical Analysis Plans and collaborating with cross-functional teams to ensure regulatory compliance.
Provide statistical leadership for the design and analysis of Real-World Evidence (RWE) and observational studies. Collaborate with cross-functional teams to support publication strategies, HEOR modeling, and evidence generation for post-marketing and payer analysis.
Lead and support the delivery of technical programming and information components for clinical projects. Develop, validate, and maintain SAS programs for data analysis and reporting while collaborating with cross-functional teams.
Lead the development of analysis specifications and programs for Real-World Data research across diverse therapeutic areas. Ensure methodological rigor through patient cohort development and the validation of key variables.
Provide statistical leadership for Phase I-III oncology clinical trials, including the development of SAPs, protocols, and CSRs. Collaborate with cross-functional teams to support regulatory submissions and respond to health authority queries.
Lead statistical strategy, analysis, and reporting for clinical trials within the Vaccines & Infectious Diseases therapeutic area. Collaborate with cross-functional teams to ensure high-quality deliverables and regulatory compliance for FDA and EMA submissions.
The Senior Statistical Programmer will program and validate clinical trial datasets, tables, and listings while overseeing deliverables from external CROs. They will also contribute to the design of statistical analysis plans and ensure high-quality electronic submissions compliant with industry standards.
The Regional/Senior Artwork Controller manages the complete end-to-end artwork development process, from brief to final release, ensuring timely delivery of high-quality, compliant labeling components by coordinating various internal teams and external vendors. This role involves hands-on execution while also supervising Artwork Controllers and driving continuous process improvements within the artwork workflow.
The Regional/Senior Artwork Controller manages the complete end-to-end artwork development process for packaging and labeling components, ensuring timely delivery of high-quality, compliant materials by coordinating various internal teams and external vendors. This role involves hands-on execution, driving process improvements, investigating issues via RCAs/CAPAs, and supervising junior Artwork Controllers.
