Trigent Software Inc | Statistical Programmer | india
3 days ago
Note: (5-6 Months Remote then Onsite)
Responsibilities:• Develop and maintain programs using R to generate Tables, Listings, and Figures (TLFs) as part of clinical trial reporting.• Implement CDISC standards (SDTM, ADaM) for clinical data submission and reporting.• Manage clinical datasets and ensure data integrity, quality, and compliance with industry standards.• Validate datasets, perform quality checks, and troubleshoot issues to ensure accurate reporting.• Work closely with clinical data managers, statisticians, and project managers to understand data requirements.• Provide programming support for regulatory submissions and ad-hoc analysis requests.• Develop automated processes to streamline workflows and improve reporting efficiency.• Stay updated with advancements in R programming and clinical data standards.• Prepare detailed documentation, including specifications and programming guidelines, to meet regulatory and compliance standards.• Ensure all programming activities align with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).• Prepare regular progress reports and communicate project updates effectively to stakeholders.• Address programming challenges and propose innovative solutions for data management.
Qualifications:• Proficiency in R programming, with hands-on experience in CDISC standards (SDTM, ADaM) and TLFs generation.• Strong problem-solving skills, attention to detail, and the ability to work independently in a remote environment
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