are: Represent Statistics in all assigned cross-functional clinical study teams and other projects and holds him/herself accountable... into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications...
Development Scientists. Collaborate closely with study teams to ensure high-quality clinical documentation, including protocols... understanding of the end-to-end drug development process-from interpretation of non-clinical data to clinical study design...
communication with scientists and study directors, while maintaining the Vertex Comparative Medicine tradition of compliance... with serious and life-threatening diseases. Animal health and wellbeing is considered essential to scientific rigor and data integrity...
to Management and determine how individual study results impact the overall compound strategy. Interprets data from an overall...-medical clinical scientists with respect to assessment of these issues. Makes final decisions regarding study conduct related...
and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects. Ability.... This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity...
Pharmaceuticals where research, development, and clinical manufacturing are highly integrated together at our new R&D site in Boston... for multiple indications. Collaborate with clinical and supply chain teams to prepare clinical study documentation. Collaborate...
-on review, validation, and troubleshooting of SAS/R programs for data transformation, analysis, and reporting. Ensure accuracy... of efficacy/safety outputs, perform QC, and resolve discrepancies. Serve as the primary programming point of contact for study...
understanding of FDA, EMA, ICH, and global regulations and guidelines. Deep knowledge of clinical study data standards... with SOPs and regulatory standards. Collaborate with Biostatistics, Clinical Development, Data Management, and Regulatory...
opportunity to work in a biotech-like environment where cross-functional research aims to discover and develop novel therapeutic... with scientists from various disciplines and backgrounds. How You Will Contribute: Actively participate in the planning...
, oversight, and guidance to team of Clinical Program Leaders, Clinical Research Physicians and Clinical Research Scientists...Chiesi USA Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years...
scientific rigor, data quality, compliance with global regulatory standards, and relevance of the project objectives and outcomes... to organizational goals. Essential Duties and Responsibilities Clinical Research and Clinical Utility Expertise: Operate internally...
direction of clinical scientists involved in developing documents required to outline the Company positions on research programs.../China) Development Team for a given product. May lead the Development Sub Teams or study teams and represents Clinical...
Safety sub-teams (represented by toxicology, pathology, study management, DMPK, and CMC) which manage the operational... execution of the nonclinical safety strategy for each program Collaborate with other functional groups (study management...
, and perturbational datasets to study various aspects of tumor evolution under the supervision of a research advisor; contributing... at lab meetings; and working collaboratively with other technicians and post-docs and research scientists in our laboratory...
-edge technologies to study multiple aspects of tumor evolution; contributing to, and possibly lead, research projects... that will appear in conferences and scientific journals; curating publicly-available cancer data resources for research projects...
study data, and ensuring that adverse events are reported and managed appropriately. Contribute to and/or lead the creation... with biostatisticians to develop analysis plans, reviewing study data, and interpreting study results. Work to improve the quality...
studies supporting the analytical validity of the product as well as post-launch data. Lead of the development and execution... of ingenuity and innovation. Partner with scientists to guide and support the planning and delivery of impactful evidence...
scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital... of clinical study designs, analysis methodology and data interpretation. Advanced knowledge of pharmaceutical industry, overall...
, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Data Auditing, Data Management.... A dynamic group of Clinical Trial Leaders (Clinical Scientists) who plan and execute early phase trials worldwide. From First...