We are looking for experienced Statistical Programming professionals to join our team and support clinical development, analysis, and regulatory submission activities.
Positions: Statistical Programming Consultant / Senior Statistical Programmer
Experience:
• Consultant: 4–6 years
• Senior: 6–8 years
Education: Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or related field
Key Skills & Responsibilities:
• Strong hands-on experience in SAS / Clinical Statistical Programming
• Develop SAS programs for ADaM datasets, Tables, Listings & Figures (TLFs)
• Perform programming validation and ensure quality of datasets and outputs
• Strong understanding of CDISC standards, SDTM, ADaM, and clinical data structures
• Experience with clinical data processing, including eDC, SDTM, and upstream data sources
• Generate downstream deliverables including ADaM, Data Definition Tables, and e-submission packages
• Support regulatory submissions and review submission-related deliverables
• Review and interpret Statistical Analysis Plans (SAPs) and other clinical planning documents
• Work with vendors on programming standards, specifications, conventions, and data transfers
• Ensure compliance with regulatory requirements, SOPs, and industry standards
• Experience with Pinnacle 21, XML, relational databases, and MS Office
• Strong understanding of clinical trials, statistical terminology, medical terminology, and protocol design
Good to Have:
• Experience supporting NDA, BLA, MAA, or other regulatory filings
• Knowledge of the drug development process and global regulatory requirements
• Experience with R
• Exposure to Linux/Unix environments
Interested candidates Share your updated resume to [HIDDEN TEXT] or apply through LinkedIn.
Skills Required
cdisc standards , protocol design , Relational Databases, Sdtm, Ms Office, Xml, EDC, Medical Terminology, Regulatory Submissions, Sas, Linux, Unix
Statistical Programmer Clinical SAS • Bengaluru / Bangalore, India
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