- Merck & Co. (North Wales, PA)
- …Life Sciences, Engineering, or related field plus 9 years in a clinical trial environment ( Analysis & Reporting,- Information Technology, Data Management ... Life Sciences, Engineering, or related field plus 6 years in a clinical trial environment ( Analysis & Reporting,- Information Technology, Data Management… more
- Merck & Co. (North Wales, PA)
- … analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent ... and provide biostatistical support for related drug/vaccine projects in Clinical Safety StatisticsLead the interaction with Safety Physicians, Clinical… more
- Merck & Co. (North Wales, PA)
- … analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent ... Lead and provide statistical support for related drug/vaccine projects in Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical … 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 ... Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …payer evidence, economic models, and Global Value Dossiers- Propose and implement analysis of clinical trial data for cost effectiveness models and market ... including the implementation of global health economic models, global value dossiers, RWE studies, PRO analysis , and...key and visible expert leader, he/she will engage the clinical , Medical Affairs and commercial organization and drive the… more
- Merck & Co. (Rahway, NJ)
- …benefit of patients and global human health. The Associate Principal Scientist, Clinical Trial Analysis and Reporting leads the statistical programming ... quality , compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems… more
- Merck & Co. (North Wales, PA)
- …technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.Develops ... to ensure that the data evaluated are in high quality and satisfy analysis requirements.May lead a...individual investigators.Provides responses to queries relating to study design, analysis , and interpretation posed by the clinical … more
- Merck & Co. (North Wales, PA)
- …of potential medical breakthroughs.Review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high- ... quality data to support decision making in clinical trials.Support statistical programming activities for Early Oncology clinical development… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Inc., where a PharmD's training and expertise will provide value to the organization. The fellow will gain the… 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 ... execution of statistical analysis and reporting deliverables (eg safety and efficacy ...listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post… more
- Merck & Co. (Rahway, NJ)
- …with cross functional teams within Biologics and Vaccines AR&D, Global Quality , Upstream/Downstream Process Development, Formulations, Global Clinical Supply, ... strategy development and execution with a sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and… more
- Merck & Co. (North Wales, PA)
- …market access in collaboration with internal teams, and provide input into clinical , payer/access, marketing and value evidence generation strategies and ... American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers.Develop supplementary clinical data package for submission to Health… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Merck & Co. (Rahway, NJ)
- …- Strong background and experience in separations science - Extensive experience with UPLC/HPLC analysis of biologics ( eg, SEC, RP, IEX) and CE techniques . - ... in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/ QbD /DOE principles as well as data... Attributes/ QbD /DOE principles as well as data analysis and statistics for setting specifications - Ability to… more
- Merck & Co. (Lower Gwynedd, PA)
- …the vaccine and biologic therapeutic area through development, optimization, validation, clinical and pre- clinical testing. This specific position will support ... methods, evaluate new techniques, validate, and trouble-shoot molecular assays and test pre- clinical and/or clinical samples as needed. Experience in qPCR,… more
- Merck & Co. (Lower Gwynedd, PA)
- …staining (ICS), ELISpot/FluoroSpot and cytokine profiling for preclinical and clinical studies. Communicate strategy, results and interpretation effectively to ... accountable for achieving program timelines and deliverablesUnderstand and implement statistical analysis tools to lead group in complex multiparameter data … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of cell therapy reimbursement. Shape the payer value story, supported by credible clinical , health economics and quality of life messages as the market and ... to inform clinical trial programs, guide evidence generation development, payer value stories, and develops market access (pricing, contracting, and value … more
- Merck & Co. (Lower Gwynedd, PA)
- …with primary immune cells to develop bioanalytical assays capable of meeting clinical assay standards. The candidate should be current on state-of-the art ... cytokine staining (ICS), ELISpot/FluoroSpot and cytokine profiling for preclinical and clinical studies. Interpret, summarize and report complex data sets with clear… more
- Merck & Co. (Rahway, NJ)
- …solving.Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... in the pharmaceutical industry.-Required Experience and Skills:Extensive experience in analysis of biologics (separation methods such as Size Exclusion… more
- Merck & Co. (Rahway, NJ)
- …Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations & Clinical Supplies (Pharm Ops) organization. The SLP and FLEx facility ... supports the formulation and filling of clinical , stability, and developmental supplies for Oral Solid Dosage...initiatives and metrics, assisting in safety investigations and root-cause analysis (RCA), as well as support of various departmental… more
