- Eisai, Inc (Nutley, NJ)
- …the scientific expertise, the incumbent must be capable of analyzing and interpreting study data and effectively communicating findings to a broad audience. The ... data .Serves as Medical Monitor (where applicable) to review and monitor study data .Implements strategies to identify, monitor and resolve clinical… more
- Eisai, Inc (Nutley, NJ)
- …development and the communication of clinical, real-world, health economics outcomes data . This role primarily focuses on late-stage pipeline and marketed products, ... and appropriate utilization based on generation and communication of quality data . Essential Functions Educate population-based decision makers on health economic… more
- Eisai, Inc (Nutley, NJ)
- …of that plan.Champion CQA's mission of 'Quality as enabler of business'; lead global initiatives for continuous improvement.Trend and leverage internal audit ... the workforce to evolving technologies.Align clinical portfolio, business strategy, clinical studies , and related functions eg data management, clinical… more
- Sanofi (Morristown, NJ)
- …our teams accelerate progress. Join our Clinical Science Organization as an AI-Enabled Global Study Leader and you'll drive digital transformation across ... get started? Main Responsibilities Lead the cross-functional study team and oversee global study... study team and oversee global study processes including protocol development, enrollment, data … more
- Merck & Co. (Rahway, NJ)
- … study reports and regulatory submissionsEnsure programmatic traceability from data source to modeling resultSupport the development of programming standards to ... and experience in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, listings)A project leader ; completes tasks… more
- Formation Bio (New York, NY)
- …acquiring and developing a portfolio of clinical-stage assets and looking for an IP leader who shares our vision and energy to protect, enhance, and maximize the ... will work closely with our business development, legal, clinical, CMC, and data /engineering teams to on-board products with strong IP potential, and thereafter… more
- Formation Bio (New York, NY)
- …knowledge through internal and external partnership. Responsibilities Oversee GXP, Data Integrity, and CSV activities across various entities, investigator sites, ... research organizations, clinical and nonclinical studies , PV vendors, and CDMOs. Maintain efficient systems and...and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the effective review… more
- Merck & Co. (Rahway, NJ)
- …and programs.In collaboration with internal teams and external partners, designs studies ; authors study protocols; and develops measurement questionnaires, case ... Research, position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes...report forms, data analysis plans, final study reports, scientific… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The ... ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our Company is on a quest for cures and is committed to… more
- Merck & Co. (Rahway, NJ)
- …marketing of medical drugs and vaccines for the benefit of patients and global human health. This position is for a principal scientist in biostatistics.-The ... knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and… more
- Organon & Co. (Jersey City, NJ)
- …design, execution (in collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies in accordance with ... Lead also will be responsible for the rationale, study design and oversight of phase 1 to 2a...selection and provide vendor oversight and management for TMED studies , in collaboration with the TMED operations lead… more
- Sanofi (Morristown, NJ)
- …cutting-edge AI technologies to revolutionize how we prepare and execute clinical studies . Our team is passionate about using data -driven approaches to ... Through the early generation of operational insights to support indication-level and study -level planning, organizing and execution of clinical studies , this… more
- Sanofi (Morristown, NJ)
- …and/or research, clinical and analytical bioassay development Contribute to the setup of the study to make sure data are adequately captured and collected to ... scientific content: Selects statistical methodology to support the objectives of the studies , Drives risk assessment for study conclusions if applicable,… more
- Organon & Co. (Jersey City, NJ)
- …CTM will support the TMED Operations Lead to plan and execute studies including, but not limited to, managing study timelines, reviewing/approving study ... studies . **Responsibilities** + Manage and support the operational aspects of clinical studies from study start-up through close-out. + Manage and serve as… more
- Sanofi (Morristown, NJ)
- …Specialty Care sponsored clinical studies , including Phase 3 and 4 studies , and exploratory analyses. This position supports Global Medical Affairs and ... Job Title: Biostatistics Lead , Next Generation Immunology Location: Cambridge, MA Morristown,...and/or conducting statistical analyses based on experimental or observational data from human studies , including substantial experience… more
- Sanofi (Morristown, NJ)
- … Simultaneous Submissions (GSS), they partner in an agile model with the Submission Lead and global colleagues to provide regional expertise and execute the ... Job Title: Global Submission Manager Location: Cambridge MA Morristown, NJ...with GRA and Digital functions as SME for current processes/ data /technologies, as well as evaluating and implementing new/emerging technologies… more
- Sanofi (Morristown, NJ)
- Job title : Statistical Team Leader , Neuroscience and Ophthalmology TA Biostatistics (Director) Location : Morristown, NJ, Cambridge, MA About the Job Are you ready ... Biostatistics, Clinical Statistical Modeling, and Real-World Evidence to revolutionize data -driven decision making through cutting-edge quantitative science and deliver… more
- Organon & Co. (Jersey City, NJ)
- …of all regulatory milestones for assigned products through the product lifecycle.? + Lead development and execution of global product and project regulatory ... for assigned small molecule or biological products in accordance with global regulations and guidances, and Organon procedures. The Associate Principal Scientist… more
- Sanofi (Morristown, NJ)
- …and/or program can be evidenced because of the collaboration (eg Patient Experience Data (PED) utilized to optimize study design, PED integrated into Regulatory ... Job Title: R & D Patient Engagement Country Lead Location : Cambridge, MA Are you ready...locally, focusing on both the forward (eg local to Global Project Teams) and back (eg Global … more
- Organon & Co. (Jersey City, NJ)
- …teams (ADTs). This position will report to the Non-Clinical Safety Assessment Lead . The NCD team is comprised of non-clinical drug development scientists ... asset development teams (ADTs). + Plans and executes non-clinical safety studies and assessments at appropriate stages to support asset progression through… more
