- Merck & Co. (Rahway, NJ)
- …life sciences, preferred.Ideal candidate would have:Experience in conducting global clinical trials, including trial initiation through database lock.Experience ... SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Merck & Co. (Rahway, NJ)
- …lead our data management team in supporting the pharm and vaccine veterinary clinical trials. The ideal candidate will be responsible for overseeing the development ... and maintenance of clinical databases and ensuring the integrity, consistency, and confidentiality...and seamless transfer of external data to the primary database or data warehouse systems.- Innovative Process Development:-Drive the… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!Job DescriptionDirector, Clinical Research ScientistServe as a key role in contributing to the scientific and ... expertise in a therapeutic area leading one or more clinical trials for one or more compounds in various...and provide scientific support for other key deliverables (eg database lock activities)Lead the development of the medical data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical ... Monitor. Represents Clinical Development on Study Team and collaborates as team... data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Merck & Co. (North Wales, PA)
- …Systems Pharmacology (QSP) . QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology, mechanistic PK-PD modeling and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting- ... and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros or tools… more
- Genmab (NJ)
- …us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of ... the vendorSupports compound responsible programmer in developing an integrated database specificationCDT member:Responsible for giving statistical input to overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Forum(s) that focus on systemic aspects of performance and delivery of global clinical operations. 2) GCO capacity demand and supply & resourcing strategies 3) GCO ... GCO technology needs 5) GCO financial processes The role is part of the Clinical Trial Business Operations (CTBO) group in Global Clinical Operations (GCO).… more
- Merck & Co. (North Wales, PA)
- …:This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (North Wales, PA)
- …support to statistical programming activities for late-stage drug/vaccine clinical development projects. Develop and execute statistical analysis and ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Genmab (NJ)
- …us!The Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and… more
- Merck & Co. (Boston, MA)
- …in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Associate Directors are emerging leaders in the field of quantitative drug… more
- Merck & Co. (South San Francisco, CA)
- …ms of experienced sci e ntis ts to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and ophthalmologic diseases. You ... model-based strategies ( translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within and across… more
- Merck & Co. (South San Francisco, CA)
- …mechanisms of action, and to help identify potential clinical biomarkersIntegrate high-throughput assays, including genomics, transcriptomics, and proteomics ... applying and implementing both fundamental and advanced statistical techniques for non- clinical and clinical studiesStrong programming skills with applications… more
- Aequor (IL)
- …Description:Hard Skills1. ERP Systems - Proficiency with SAP/Ariba a plus.2. Database Management - Data entry and accuracy.3. Vendor Management - maintain ... Skills1. Problem solving.2. Takes Initiative.3. Interpersonal communication.Job ResponsibilitySupport Global Clinical Supply (GCS) in management of GCS PO requisition… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... collection/processing strategies and in generating outputs using suitable Pharmacovigilance database retrieval strategies. Experience with safety data collection and… more
- Merck & Co. (San Francisco, CA)
- …PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs ... approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming critical drug development questions for… more
- Genmab (NJ)
- …functions including Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology,Translational Research, Medical Writing, Project management, and ... studies Supports the establishment and maintenance of Genmab SDTM and ADaM database standards. Supports specification and pooling of data across clinical … more
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