- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Position manages the end-to-end delivery of data management services for assigned projects/ studies , collaborating with CROs and other vendors to ensure high quality ... Management and collaborates cross-functionally to ensure successful outcomes for projects/ studies .This position has strong knowledge of Electronic Data Capture/related… more
- Eisai, Inc (Nutley, NJ)
- …overseeing statistical activities across a diverse portfolio. This portfolio includes studies related to Alzheimer's disease (AD) dementia and various other ... project teams. This involves providing valuable statistical input on observational studies , actively participating in the formulation of study designs and defining… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and ... PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies , literature, regulatory guidelines, and physiological/pharmacological aspects of the drug. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good ... activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS) Support the preparation, set-up, and execution and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data collection, data standards and data cleaning needs for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during the ... of all external data management deliverables for assigned DS Program / Studies by ensuring consistency of external data standards.Is accountable for quality delivery… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Research Coordinator will work with a research team on several federally-funded studies designed to evaluate the behavioral and physiological effects of nicotine and ... tobacco use in human research participants, as well as other studies as needed. Responsibilities include:Oversees, organizes, and executes daily activities for… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division functional areas in designing and analyzing CMC-related studies , and in coordinating other statistical activities for drug/vaccine ... problems arising in the design, conduct, and analysis of CMC-related studies , proposes solutions and carries them out.Contributes to individual protocols and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation ... and Clinical Study Report (CSR): Leads statistical activities for very complex studies or an entire project. Act as statistical expert in the assigned… more
- Merck & Co. (Durham, NC)
- …and deliverables related to the vaccine process Lead technical studies and author documentation associated with equipment, cleaning, and sanitization/sterilization ... activities. Support technical studies including engineering runs, stability and process validation activities by maintaining systems in a validated state. Provide… more
- Merck & Co. (North Wales, PA)
- …the publication of biomarker and translational research for respective studies .Analysis, interpretation & impact: collaborate with forementioned line functions to ... effort.Drive the publication of biomarker and translational research for respective studies .Qualifications:PH.D. MD or MD/Ph.D. with a minimum of 8 years' experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Position manages end-to-end delivery of data management services for assigned projects/ studies , collaborating with CROs and other vendors to ensure high quality ... relevant regulatory requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for developing the Global Clinical Science Strategy and delivery of clinical studies in late stage developmentLead and manage the multiple late development and/or ... that adequate (Oncology) Clinical Science resources are deployed to clinical studies from end to end in collaboration with GCLs, Physician Scientists… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and participate in ... teams.ResponsibilitiesResponsible for all aspects of clinical pharmacology and biopharmaceutics studies ; clinical pharmacology project lead; supports Phase 2/3 clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design, independently ... clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of results ... and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis… more
- Insmed Incorporated (Bridgewater, NJ)
- …be responsible and accountable for designing clinical pharmacology programs and studies , performing PK and PKPD data analysis, supporting clinical dose selection ... supporting assigned programs in clinical developmentLead and design clinical pharmacology studies and provide clinical pharmacology support to late phase clinical … more
- Merck & Co. (Rahway, NJ)
- …investigational or marketed Oncology drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as ... the activities of Clinical Scientists in the execution of clinical studies ;Work closely with a cross-functional group of experts in commercialization, regulatory… more
- Aequor (South San Francisco, CA)
- …will be supporting the larger PTPK department in their execution of PK studies of molecule characterization as well as preclinical models development to determine ... PK Scientists on PK study designs, coordination and monitoring of these PK studies working with internal and external collaborators. The role will include PK data… more
- Merck & Co. (San Diego, CA)
- …site. The focus will be on preclinical and IND-enabling in vitro studies . The ideal candidate thrives in a fast-paced, matrixed team.Job responsibilities:Lab-based ... role focusing on preclinical and IND-enabling studies for novel therapeutics for immunological diseasesDesign and execute in vitro functional assays to support… more
- Eisai, Inc (Nutley, NJ)
- …biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for biomarker development, this individual primarily will ... managing CROs. The immediate need is to manage early clinical development studies primarily in support of Translational Science and Clinical Pharmacology related to… more
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