Responsibilities
- Lead the development and implementation of submission ready SDTM datasets in accordance with regulatory requirements (, 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 years of experience in Statistical & Clinical programming, with a focus on submission expertise, within the pharmaceutical or biotechnology industry.
- Proficiency in programming languages such as SAS and R.
- Strong knowledge in Windows and UNIX environment, with proficiency in SAS / Base, SAS Macros, SAS / Graph, SAS / SQL, SAS Grid, SAS Enterprise Guide, CDISC, SDTM, MedDRA, WHO DRUG.
- Deep understanding of CDISC standards and regulatory submission requirements.
- Proven experience in preparing and submitting SDTM datasets for regulatory filings (, IND, NDA, BLA).
- Strong attention to detail and a commitment to ensuring the quality and integrity of submission datasets.
- Experience with EDC systems (, Medidata Rave, Oracle Clinical) and other tools (Review, Spotfire, Tableau) is a plus.
- Experience with Oncology and Neuroscience Therapeutic areas is a plus.
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Strong knowledge in Windows and UNIX environment, with proficiency in SAS/Base, SAS Macros, SAS/Graph, SAS/SQL, SAS Grid, SAS Enterprise Guide, CDISC, SDTM, MedDRA, WHO DRUG. Minimum of years of experience in Statistical & Clinical programming, with a focus on submission expertise, within the pharma...
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