Senior Statistical Programmer

1 week ago

Kolkata, India Whatjobs IN C2 Full time

We are seeking a highly skilled Lead Statistical Programmer with expertise in SAS and R programming to support clinical trial data analysis and regulatory submissions. The ideal candidate will author and validate programs, manage client projects, and ensure compliance with CDISC standards and regulatory requirements. Key Responsibilities: Author, validate, and document SAS programs for datasets, TFLs, and macros, applying good programming practices. Develop and maintain programs in R , with hands-on experience in packages such as Tidyverse, Admiral, Create ADaM datasets using Admiral packages in R. Read and write raw data across SAS and R platforms. Conduct thorough debugging using R console tools. Review and approve clinical trial documents, dataset specifications , and TFL shells . Identify and resolve data issues, outliers, and standards-related discrepancies. Complete, review, and approve CDISC Validation Tool reports. Stay updated on emerging CDISC standards and assess impacts on ongoing and future trials. Maintain proficiency in SAS and awareness of developments in programming tools and standards. Ensure all study master file documents are audit-ready . Serve as Lead Programmer on client accounts and projects, managing client expectations and providing issue resolution. Provide input into and review of project management documents . Perform all work in full compliance with applicable legislation, regulations, company policies, and procedures . Actively contribute to internal and client study team meetings . Qualifications & Skills: Bachelor’s or Master’s degree in Statistics, Computer Science, Life Sciences , or a related field. Proven experience in SAS programming within clinical trials or pharmaceutical/CRO settings. Strong hands-on experience with R programming and relevant packages. Knowledge of CDISC standards (ADaM, SDTM) and regulatory submission requirements. Excellent problem-solving, debugging, and data validation skills. Strong communication skills to manage client interactions and cross-functional collaboration. Ability to work independently as well as lead project teams. Preferred Experience: Exposure to regulatory submissions and audit processes. Experience as a Lead Programmer managing timelines, deliverables, and client relationships.

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