- Merck & Co. (North Wales, PA)
- …of one or more clinical trials in the lung cancer program. Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical ... CRA training materials.Prepare clinical narratives.Collaborate cross-functionally to monitor clinical study data to ensure quality, completeness, and… more
- Merck & Co. (North Wales, PA)
- …particularly in meta-analysis and bayesian methodologies.Solid knowledge of- statistical and data processing software eg SAS and/or R.-Good project management ... and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the… more
- Merck & Co. (Rahway, NJ)
- … data , biomarker data , and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as ... Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials...guidance of more senior staff, may serve as the data management lead or perform a support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within ... patients who are likely to benefit from our therapeutics.Responsibilities:- Leads CDx project teams for the diagnostic, in full alignment with Global Program Teams… more
- Eisai, Inc (Nutley, NJ)
- …related to both clinical trial setting and observational studies.Serve as the lead statistician on project teams, offer statistical insights into clinical ... but are not limited to, serving as the statistical lead on project teams. This involves providing...timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in...activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical ... External Data Management, is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) ... Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing the defined,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company, or ... Management, is accountable for the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical...external data management activities by managing external data processes including providing guidance to Project … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director, Clinical Safety, will be a product safety lead or part of a ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance....In this key role, the candidate will have to lead a complex, global team in charge of a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Strategy:Provides data management (DM) expertise and guidance to the project team regarding the data management DM activities and deliverablesEstablishes ... Data Management strategy at the project and/or study level for a larger number of...effectiveLeads functional and/or multidisciplinary teams working on projects/studies and/or initiatives. Lead and manage the standardized Data Management… more
- Merck & Co. (Rahway, NJ)
- …projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management, and other Company ... benefit of patients and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides… more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and ... Organization (CRO) and external statistical consultants.This position may serve as a statistical lead in project teams.The incumbent may initially work in a… more
- Merck & Co. (Rahway, NJ)
- …patients and global human health. Responsibilities :Serves as a statistical lead in project teams.Develops, coordinates, and provides biostatistical leadership ... support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and other… more
- Merck & Co. (North Wales, PA)
- …and meeting notes.With minimal oversight, provide therapeutic area expertise to lead scientific strategy discussions around appropriate data dissemination ... least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …macros and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming ... training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros… more
- Eisai, Inc (Nutley, NJ)
- …impact analyses of health technologies.Serve as the subject matter expert and independent project lead responsible for overseeing all aspects of project ... with academic institutions and vendors, develops and maintains client relationships.As project lead /principal investigator has project budget, deliverable… more
