- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct ... regulations such as site and vendor selection, preparing clinical trial budgets. Ensures study is conducted within clinical ...trial budgets. Ensures study is conducted within clinical trial protocols. Monitors progress and follows up with team… more
- Genmab (NJ)
- …indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Associate Director ... courses and perform professional networkingEngage with regulatory authorities on trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab… more
- Merck & Co. (North Wales, PA)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical ... clinical data to ensure quality, completeness, and integrity of trial conduct.Providing tactical/scientific mentorship to other clinical scientists.Core SkillsDemonstrated… more
- Merck & Co. (Rahway, NJ)
- …This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical ... clinical data -to ensure quality, completeness , and integrity of trial conduct. Providing tactical/scientific mentorship to other clinical scientists. Core Skills… more
- Merck & Co. (North Wales, PA)
- …Responsibilities: Responsible for the operational planning, feasibility, and execution of a clinical trial .May serve as the clinical trial team leadMay lead team ... planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates,… more
- Merck & Co. (Rahway, NJ)
- …strategies ( translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within and across development ... of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. Represent QP2 on cardiometabolic and ophthalmology… more
- Merck & Co. (North Wales, PA)
- …field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and… more
- Merck & Co. (Rahway, NJ)
- …field plus 5-9 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... related field plus 3-7 years SAS programming experience in a clinical trial environment Department Required Skills and Experience: Effective interpersonal skills and… more
- Genmab (NJ)
- …compound lead, primarily up until proof of concept, and/or as trial responsible statistician.Responsibilities:Compound/Indication LevelAct as lead and main point of ... courses and perform professional networkingEngage with regulatory authorities on trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab… more
- Formation Bio (New York, NY)
- …medical image analysis, focusing on MRI and X-ray modalities for clinical trial applications Design and implement automated image processing pipelines for disease ... endpoints Collaborate with clinical operations to integrate imaging AI solutions into trial protocols and workflows Partner with regulatory teams to ensure imaging… more
- Merck & Co. (North Wales, PA)
- …for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial Team lead. Leads and ... subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management team . Review… more
- Merck & Co. (Rahway, NJ)
- …or related field plus 3 years SAS programming experience in a clinical trial environment OR a Bachelor's degree in Computer Science, Statistics, Applied Mathematics, ... related field plus 5 years SAS programming experience in a clinical trial environment.Minimum requirement:Must have experience in CDISC SDTM and ADaM standards.Must… more
- Merck & Co. (South San Francisco, CA)
- …strategies ( translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within and across development ... of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. Represent QP2 on cardiometabolic and ophthalmology… more
- Merck & Co. (Rahway, NJ)
- …as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.Develops individual protocols and data analysis ... research activities for innovative statistical methods and applications in clinical trial developmentEducation & Skills Education and Minimum Requirement: PhD or… more
- Merck & Co. (North Wales, PA)
- …a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The knowledge must be sufficient ... and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff… more
- Merck & Co. (Rahway, NJ)
- …Clinical Neurophysiology, Clinical Research Management, Clinical Testing, Clinical Trial Development, Data Analysis, Decision Making, Drug Development, Intellectual ... Strategic Planning, University Education-Preferred Skills:Clinical Research, Clinical Studies, Clinical Trial Protocols, Clinical Trials, Early Clinical Development, Neuroscience, Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …detection and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant within company ... direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for… more
- Merck & Co. (Boston, MA)
- …(PK) and pharmacodynamics (PD) analysis, model-based meta-analysis (MBMA), clinical trial simulations (CTS), pediatrics modeling and disease progression modeling. In ... approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions Serve as a subject matter expert and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents… more
- Merck & Co. (Rahway, NJ)
- …field plus 5 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... field plus 3 years SAS programming experience in a clinical trial environmentDepartment Required Skills and Experience: Effective interpersonal skills and ability… more
