Associate Director, Data Operations

Overview In this role you drive data operations for the Neuroscience Group, focusing on end-to-end data flows from collection to submission. You will shape SDTM data production and CDISC standards in a global pharma setting, collaborating with cross-functional teams to ensure high-quality analytical datasets. You’ll introduce new technologies to streamline processes and support regulatory submissions. This is a hands-on leadership role with a clear impact on data standards, quality, and timeliness. ResponsibilitiesLead execution of key department objectives and projectsDevelop, modify, and implement operational policies affecting clinical data processesOversee SDTM data production including specification, programming, QC, and deliverables for analyses and submissionsImplement new technologies to streamline data collection, processing, and submissionEngage stakeholders to establish SDTM standards and facilitate transition of clinical data to SDTMEnsure SDTM datasets specification, conversion, and timely delivery to stakeholdersAssist in annotating CRFs per CDISC guidelines and review annotations and datasets produced by othersOversee or contribute to cross-functional process improvements and quality assurance across datasets and programming specificationsProvide SDTM data production technology support to Clinical Data Operations and lead a team with a shared focus Key requirementsExpertise in addressing technical challenges linking EDC, SAS, CDISC, and XMLExcellent SAS system and application development skillsExperience implementing CDISC data standards in a global pharmaceutical environmentProficiency in integrating SAS with PDF, XML, and Microsoft Office for electronic submissionsExperience in CDISC CDISC standards across CRF annotations and SDTM data life cycleExperience in reviewing and QA of CRF annotations, datasets, and programming specificationsStrong focus on process improvements and cross-department collaboration for SDTM data productionAccountability for SDTM data production processes and timely deliverablescollaborationprocess-improvementstakeholder-communicationEDCSASCDISC