Responsibilities :
Lead the development and implementation of submission-ready SDTM datasets listings (not TLFs) in accordance with regulatory requirements (e.g., FDA, EMA, PMDA).
Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards.
Perform thorough quality control checks to validate the accuracy and completeness of submission datasets.
Coordinate the preparation and documentation of submission packages, including data specifications and validation documentation.
Serve as a subject matter expert on submission-related matters, providing guidance and support to cross-functional teams.
Stay abreast of evolving regulatory requirements and industry best practices related to SDTM and submission standards.
Requirements :
Minimum of 8 years of experience in Statistical & Clinical programming, focusing on submission expertise, within the pharmaceutical or biotechnology industry.
Proficiency in programming languages such as SAS and R (R is good to have).
Strong knowledge of Windows and UNIX environments, with proficiency in SAS / Base, SAS Macros, SAS / Graph, SAS / SQL, SAS Grid, SAS Enterprise Guide, CDISC, SDTM, MedDRA, and WHO DRUG.
Deep understanding of CDISC standards and regulatory submission requirements.
Strong attention to detail and a commitment to ensuring the quality and integrity of submission datasets.
Experience with EDC systems (e.g., Medidata Rave, Oracle Clinical) and other tools good to have (Review, Spotfire, Tableau).
Experience with Oncology and Neuroscience Therapeutic areas.
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