- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study Reports).Leads and ... diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in a pharmaceutical, biotech company, or similar environment with extensive Clinical Data Management (CDM) and Standards experience, hands-on ... including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development, maintenance,… more
- Merck & Co. (North Wales, PA)
- …appropriate by managementEducation Minimum Requirement: Bachelors degree with 1 year of clinical data management or standards experienceOrAssociates degree ... with 3 years of clinical data management or standards experienceOrHigh School/GED degree with 7 years' work years of clinical data management or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical device, ... veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end..., is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management , Scientific Operations etc) and ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and ... centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from end to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement ... or several programs.Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management...RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD… more
- Eisai, Inc (Nutley, NJ)
- …Programmer sought by pharmaceutical company in Nutley, NJ.Support clinical applications for clinical data management . Perform data review and ... and global tools and other utilities. Support different types of external clinical data transfers eg, laboratory data , PK, ECG,Tumor. Participate in system… more
- Merck & Co. (Rahway, NJ)
- …SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or ... and according to quality, compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including experience in one or more key functions (eg, clinical research, clinical operations, data management , biostatistics, project management ) ... with the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the… more
- Merck & Co. (North Wales, PA)
- …to be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... stakeholders.Position Specific Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as ... provide complex data review listings and reports to support Data Management and clinical teams.Develop, implement and maintain SAS programming standards… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trials, or academic clinical research background Working knowledge of biostatistics, data management , clinical operations and scientific and technical ... inquiries Lend clinical expertise to the Statistical Analysis Plan development and data management , and work closely with statistical programming and data… more
- Merck & Co. (North Wales, PA)
- …leadership and support for early-stage clinical oncology programs.Interact with Clinical , Regulatory, Statistical Programming, Data Management , and other ... way we approach serious diseases.The incumbent is responsible for statistical planning and data analysis of Phase I/II oncology clinical trials. This position… more
- WuXi AppTec (San Diego, CA)
- …study team operations and timeline discussion* Identify issues, and provide solutions to clinical operation and data management for issues that potentially ... of this position are to provide leadership in planning and conducting data analyses in clinical studies, and participate in planning and data analyses for… more
- WuXi AppTec (San Diego, CA)
- …submission strategy planning for statistics functionIdentify issues, and provide solutions to clinical operation and data management for issues that ... planning, and regulatory submission strategies. Provide statistical consulting to clinical study designReview study protocols and write statistical sectionsConduct… more
- Merck & Co. (North Wales, PA)
- …as statistical support for translational oncology projects and studies.-Interact with Clinical , Regulatory, Statistical Programming, Data Management , and ... clinical trials as well as analyzing oncology biomarker and clinical data .-Coordinate all statistical activities for ongoing clinical projects.Education… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Ensure close collaboration with other functional areas such as biostatistics, data management , clinical operations, pharmacovigilance, regulatory affairs, ... sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as...data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …improvement.Ensure close collaboration with other functional areas such as biostatistics, data management , clinical operations, pharmacovigilance, regulatory ... sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as...data set specifications, reviewer's guides, etc- Global Biostatistics Data Management (BDM) Strategy to Improve Drug… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIt is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and ... operations to achieve those objectives. -Under the guidance of the Regional Director, Clinical Quality Management (RCQM), and in collaboration with the … more
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