The Data Manager will lead clinical trial data management activities, including database setup, study conduct, and close-out. They will collaborate with cross-functional teams to ensure high-quality deliverables and adherence to project timelines.
Lead statistical programming activities for Gene Therapy clinical trials from study start-up through database lock and reporting. Develop, validate, and manage SAS programs for SDTM, ADaM, and statistical outputs while collaborating with cross-functional teams.
Lead statistical programming activities for oncology clinical studies from start-up through database lock and regulatory submission. Develop and validate high-quality SAS programs for SDTM, ADaM, and TLFs while providing technical guidance to junior team members.
The contractor will provide statistical expertise and operational support for oncology clinical trial projects, ensuring the accuracy and quality of statistical deliverables. Responsibilities include performing event projections, reviewing SDTM and ADaM specifications, and conducting routine study data reviews.
Provide statistical leadership across clinical development programs, including trial design, protocol development, and statistical analysis plans. Collaborate with cross-functional teams to ensure regulatory compliance and support evidence generation for pharmaceutical and biotechnology projects.
Provide statistical leadership across clinical development programs, including trial design, protocol development, and regulatory submission support. Collaborate with cross-functional teams to ensure scientific rigor and compliance throughout the drug development lifecycle.
The Senior/Principal Statistical Programmer serves as a technical lead for clinical studies, ensuring the quality and timely delivery of statistical programming deliverables. They collaborate with cross-functional teams to execute programming activities from study start-up through regulatory submission while providing technical oversight for outsourced tasks.
The Senior/Principal Statistical Programmer serves as a technical lead for clinical studies, ensuring high-quality and timely delivery of statistical programming deliverables. They are responsible for executing programming activities from study start-up through regulatory submission while providing technical oversight for outsourced tasks.
The Regulatory Affairs Associate will collaborate with project teams to review, update, and create technical documentation in compliance with EU MDR and other global standards. They will also perform quality control checks and represent regulatory affairs in cross-functional project meetings.
The Regulatory Affairs Associate will collaborate with project teams to create and update technical documentation in compliance with EU MDR and global regulatory requirements. Responsibilities include performing quality control checks, managing regulatory submissions, and acting as a liaison between cross-functional teams and local affiliates.
Lead cross-functional teams to oversee the execution of complex clinical trials while ensuring adherence to SOPs and regulatory requirements. Manage project budgets, timelines, and documentation while coordinating with sponsors, investigators, and internal departments.
The Senior Statistical Programmer is responsible for leading programming efforts, including the creation and validation of derived datasets, tables, figures, and listings for clinical trials. They will also oversee deliverables from CROs and contribute to the design and implementation of key statistical documentation and electronic submissions.
The Senior Scientist will lead core safety deliverables, including aggregate reports and safety analyses, while coordinating with cross-functional teams and stakeholders. They are responsible for signal validation, risk management plan updates, and ensuring compliance with global safety regulations and pharmacovigilance agreements.
The Principal Pharmacokinetics Scientist will lead the design, execution, and analysis of clinical pharmacology studies while providing technical expertise in PK/PD modeling. They will collaborate with cross-functional teams and clients to ensure high-quality outcomes and regulatory compliance.
The Senior Statistical Programmer leads the programming effort for clinical trials, including the creation and validation of datasets, tables, figures, and listings. They also oversee deliverables from CROs and ensure compliance with industry standards for electronic submissions.
The Senior Statistical Programmer Consultant supports clinical study programming deliveries by implementing protocol requirements and ensuring high-quality technical output. They also oversee documentation, contribute to best practices, and collaborate with cross-functional teams including statisticians and data managers.
The Senior Statistician is responsible for protocol development, study design, and the creation of statistical analysis plans for clinical studies. They also provide statistical oversight, ensure data accuracy, and mentor less experienced statisticians to ensure high-quality project delivery.
The Principal Statistician will lead statistical activities for clinical trials, overseeing strategy, deliverables, and cross-functional collaboration. They are responsible for authoring key statistical documents and ensuring compliance with regulatory standards.
Lead and provide statistical support for clinical studies, with a primary focus on oncology projects. Oversee statistical strategy, author key documents like SAPs, and collaborate with cross-functional teams to ensure regulatory compliance.
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 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.
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.
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.
