- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position also guides contract research organization ( CRO ) programmers and statisticians in preparing analysis files and performing ... to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project needs. The position works closely with contract research organization ( CRO ) programmers and statisticians and collaborates with internal programmers in ... guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Research Organization ( CRO ) Medical Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing eligibility ... Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan-...review- Conducts clinical data review per Integrated Data Review Plan- Accountable for the assessment of protocol… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead ... Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of sourcing strategies for a specific set of R&D categories ( CRO , Medical Writing, BDM, etc..). Builds strategic plans for specific categories under ... in class sourcing and procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of data as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Clinical Study Teams, Central & Specialty Laboratories, and CROsOversee CRO partner sample management activities per study level including sample tracking, ... the lifecycle of biosamples (eg, collection, shipping, processing, analysis, data delivery and cleaning, and final sample disposition)Support implementation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ability to leverage digital data and analytics ... supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO , Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills… more
- Aequor (Thousand Oaks, CA)
- …delivery Partner with OFSMs and GCPM representatives to provide local country landscaping data for inclusion into the program and study design and to inform/support ... experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) Preferred Qualifications BA/BS/BSc in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will be responsible for constructing translational plan documents and biomarker data analysis plans including interpretation and communication of transactional ... data and impact to key stakeholders. He or she...the external collaborations. Establish and maintain effective communication between CRO / vendors / ARO. With the Companion Diagnostics… more
- Merck & Co. (Rahway, NJ)
- …Statistics.Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Company Research Laboratories Scientists in ... projects.Interacts with Academic Research Organization (ARO), Contract Research Organization ( CRO ) and external statistical consultants.The incumbent may initially work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation in clinical studies. They will ensure that sample testing and data generation activities are completed in alignment with the therapeutic and ... or other supplemental studies to support development of Dx devices under design control process. They will lead identification and selection of Dx assays and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts ... 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts ... 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for… more
- Merck & Co. (North Wales, PA)
- …in Late Development Statistics.Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other company Research Laboratories Scientists in ... activities for clinical drug/vaccine projects. May interact with Contract Research Organization ( CRO ).This position may serve as a statistical lead in project teams.… more
- BioAgilytix (Durham, NC)
- …quality and compliance in our solutions. Our clients trust us to deliver excellence in data and bioanalysis, and this role is the last destination before our data ... then advise on corrective action, which leads us to the ultimate goal of data quality and integrity for our customers. We are looking for candidates who have… more
- Merck & Co. (Rahway, NJ)
- …mRNA-Display & high-throughput mass spectrometry) with 'at-scale' automation and ensure that data is captured, analyzed and curated in a manner enabling ML/AI (in ... peptides and CRISPR guides. Knowledge and experience working with CRO 's, externalizing/internalizing projects/assays/reagents to solve for Capacity and Capabilities.… more
- Novo Nordisk Inc. (WA)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring… more
- Veolia North America (Richmond, VA)
- …union are outlined in their collective bargaining agreement. **POSITION PURPOSE:** The Power Plant Control Room Operator is responsible for assisting in the ... a power plant. He or she will record operational data and report any abnormalities. Under general direction, the control room operator will operate, via… more
