Clinical SAS Programmer - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
Requirements:
- 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.
Source : Katalyst Healthcares & Life Sciences