- Sanofi Group (Morristown, NJ)
- …and career development goals **(10%) Regulatory Responsibilities** + Reviews and validates clinical data compliance with FDA, EMA, and ICH regulatory standards ... meetings as company representative + Monitors timely submission and dissemination of clinical data according to regulatory timelines + Coordinates planning of… more
- University of Utah Health (Salt Lake City, UT)
- …The position operates as the liaison between patient and the Transplant clinical staff in communicating relevant information by telephone and written correspondence. ... This role is responsible for maintaining the transplant data base, accurate data entry, ongoing training...standards and overall patient experience. In addition to our clinical delivery system, we have a School of Medicine,… more
- Humana (Baton Rouge, LA)
- …can adopt to meaningfully reduce readmissions. Product & Insight Development + Partner with Clinical Analytics to understand key data patterns and root causes of ... first** We are looking for a dynamic Lead Product Manager to develop clinical solutions for our members and providers, with full accountability from strategy to… more
- ThermoFisher Scientific (Wilmington, NC)
- …step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel ... frameworks for clinical research through our PPD clinical research...+ Lead and perform the assessment of medical safety data for assigned products + Develop and execute safety… more
- Cytel (Cambridge, MA)
- …of decisions. + Understand and follow FDA regulations which affect the reporting of clinical trial data . This includes good clinical practice and guidelines ... **Who Are You?** An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will… more
- UTMB Health (Galveston, TX)
- …or large complex system with a minimum of five (5) years of informatics or data /analytics experience. + Prior experience in clinical nursing practice and / or ... practice. + Participates in the development and implementation of standardized ( clinical ) data to support performance improvement, research, education, patient… more
- ThermoFisher Scientific (Greenville, NC)
- …strategic leadership and oversight of patient recruitment efforts across multiple clinical trials/indications across the client. This role will work with the ... global clinical team and leaders to understand patient recruitment needs...negotiate contracts and Quality team to ensure compliance. + ** Data Analysis and Metrics Reporting:** Utilize data … more
- Edwards Lifesciences (Frankfort, KY)
- …methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis ... (SOPs) and Work Instruction Manuals (WIMs)Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts… more
- Merck (North Wales, PA)
- …level **Position Specific Required Skills and Experience:** + Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data ... in CDISC SDTM and ADaM standards + Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH + Designs… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …of data . + Provides statistical programming support to other clinical studies or regulatory submissions where another biostatistician is assigned as the ... basic understanding of statistical concepts and techniques commonly applied to the analysis of data from clinical trials and the ability to tackle from basic to… more
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