- Merck & Co. (North Wales, PA)
- …life sciences, preferred.Ideal candidate would have:Experience in conducting global clinical trials, including trial initiation through database lock.Preferred: ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Genmab (NJ)
- …join us!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. (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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study level. Publish shiny apps for study or against integrated database - Representing cross-functional collaborations on R capabilities and systems: Collaborate ... and across compounds safety reviews (ie, ILD). Collaborate with Clinical Development and Clinical Sciences for effective...methods using SAS or R required- Advanced knowledge in database structures and set-up required Travel: Ability to travel… more
- Merck & Co. (North Wales, PA)
- …and contribute to the value evidence plan and associated studies which demonstrate clinical , economic, and patient-centered value. The work will support one or more ... evidence required by HTA/payers globally including value dossiers, evidence synthesis, clinical trial value endpoints, and support economic modeling globally (for… more
- Merck & Co. (North Wales, PA)
- …management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The knowledge must be ... principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves… more
- Merck & Co. (Rahway, NJ)
- …Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation and filling ... of clinical and developmental supplies for sterile products, including critical...where applicable, such as GMP engineering drawings and equipment database tracking.- Facilitate and/or participate in Quality Notification (QN)… more
- Merck & Co. (Rahway, NJ)
- …projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other company Research ... Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.The… 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
- Genmab (NJ)
- …Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above by developing and ... consistencySupports the establishment and maintenance of Genmab SDTM and ADaM database standards.Performs database standards consistency checks on databases… 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.… more
- Aequor (Pearl River, LA)
- …in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities ... and process automation to provide easy-to-use computational tools and large-scale database platforms. Additionally, this role involves exposure to AI/ML knowledge… more
- Merck & Co. (North Wales, PA)
- …and gain input on research design and implementation of retrospective database studies, assessment of patient reported outcomes, epidemiological studies and economic ... access and identifies value evidence needs to provide strategic input into clinical and market development programs.- Brings strong payer and HTA/reimbursement focus… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, ... analyses for any issues identified, to define CAPAs/deviationsMaintain a GRA database for tracking process deviations / CAPAsCoordinate activities required to… more
- Daiichi Sankyo, Inc. (Winston-Salem, NC)
- …hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient ... a current key customer target list, submits regular updates to the customer database and plans calls to meet goals.Reviews territorial reports with District Manager… more
- Daiichi Sankyo, Inc. (New York, NY)
- …hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient ... a current key customer target list, submits regular updates to the customer database and plans calls to meet goals.Reviews territorial reports with District Manager… more
- Chenega Corporation (Cincinnati, OH)
- …**Research Database Developer** will provide comprehensive research and clinical database services, ensuring effective development, management, maintenance ... clinical data. + Provide training and support to clinical and research staff on database usage, data management, and data integration practices and systems… more
- AbbVie (North Chicago, IL)
- …or equivalent. + Master's preferred. + Must have 8+ years of experience with clinical database design, data loading, and database modeling concepts or ... bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and… more
- Alaka'ina Foundation Family of Companies (Cincinnati, OH)
- …sensitive research and clinical data. + Provide training and support to clinical and research staff on database usage, data management, and data integration ... in health informatics, computer science, or related field + Certification in database management, clinical data management, data integration, or health… more
