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
• Solid 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
[email protected] or apply through LinkedIn.
📌 Statistical Programmer – Clinical SAS (Bengaluru)
🏢 Teamware Solutions
📍 Bengaluru