Responsibilities: Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs. Program and QC tables, listings, and f...
Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check...
Responsibilities: Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products registration. Participate on product deve...
Responsibilities: Develop and maintain SAS programs to import, clean, and validate clinical trial data. Use R for data manipulation, analysis, and visualization. Perform statistical analyses in accordance with study protocols and analys...
Responsibilities: Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs. Program and QC tables, listings, and f...
Responsibilities: Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements. Design case report forms (CRFs) for ...
Responsibilities: Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.) Create or review and app...