Statistical Programmer Clinical SAS

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 [Confidential Information] or apply through LinkedIn.