Join to apply for the Sr. SAS Programmer role at cGxPServe 6 days ago Be among the first 25 applicants Join to apply for the Sr. SAS Programmer role at cGxPServe Get AI-powered advice on this job and more exclusive features. Lead the development and implementation of submission-ready SDTM datasets 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 realeted. Responsibilities Lead the development and implementation of submission-ready SDTM datasets 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 realeted. To SDTM And Submission Standards. Requirements Bachelor's or master's degree in a relevant field (e.g., Computer Science, Biostatistics, Life Sciences). Minimum of 8 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 (e.g., IND, NDA, BLA). Excellent communication and collaboration skills, with the ability to work effectively in a cross-functional environment. 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 (Jreview, Spotfire, Tableau) is a plus. Experience with Oncology and Neuroscience Therapeutic areas is plus Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Information Technology Industries Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Get notified about new SAS Developer jobs in Matthews, NC . Charlotte, NC $100,000.00-$145,000.00 1 month ago Charlotte, NC $75,000.00-$95,000.00 17 hours ago Charlotte, NC $75,000.00-$95,000.00 3 days ago Analyst Data Analytics - US Based Remote Data Analyst – Corporate Accounting (On-Site, Charlotte, NC) Charlotte, NC $55,000.00-$68,000.00 1 week ago Finance Data Analyst (Charlotte, NC (Hybrid) or Remote) Charlotte, NC $111,605.00-$144,430.00 1 day ago Entry Level Data Analyst, application via RippleMatch Data Analyst Intern, application via RippleMatch Quantitative Analyst (Charlotte, NC (Hybrid) or Remote) Charlotte, NC $100,000.00-$125,000.00 1 week ago Data Analyst for Manufacturing & Construction Monroe, NC $70,000.00-$95,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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