- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... stakeholders to optimize Statistics technology, processes, and standards (improving quality /inspection readiness, decreasing cycle times, and reducing costs). Qualifications:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before...with delivery lead eg review TLG before DBL, and quality check of data, Works with BD&O to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manage project timelines and coordinate appropriate internal resources to create high- quality , on-time deliverables that stay within scoped timeline and budget.- ... Develops project kick-off decks, project status updates, executive summaries and case studies, and document client meetings. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable cost. Identify/develop tools for efficient vendor management.-… more
- Insmed Incorporated (Bridgewater, NJ)
- …modalities.Assure bioanalytical tasks are executed to high scientific standards, with quality , and within agreed timelines. This entails overseeing work by internal ... facilities or external vendors, within a matrix-structured environment. No bench activities are expected from this role.Provide technical expertise on sample preparation, chromatography, mass spectrometric instrumentation, stability, and other method related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... management deliverables for all studies within the project/program level meets quality , time and cost effectiveLeads functional and/or multidisciplinary teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory ... standard template on datasets and TFLs to improve efficiency and quality . Responsibilities include: contribute to CRF and SDTM standard development, develop,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... global regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, including… more
