Role & responsibilities

- Programming & Validation
- Develop, test, and validate SDTM and ADaM datasets according to CDISC standards.
- Program Tables, Listings, and Figures (TLFs) in support of clinical study reports (CSRs) and regulatory submissions.
- Translate statistical analysis plans (SAPs) into accurate and efficient code.
- Project Support
- Serve as the lead programmer on individual studies or studies within a program.
- Collaborate with cross functional teams including Biostatisticians, Clinical Data Managers, and Regulatory personnel.
- Ensure timely and accurate delivery of programming deliverables to support clinical timelines.
- Quality & Compliance
- Conduct independent quality checks on programming outputs.
- Maintain programming documentation according to internal SOPs and regulatory guidelines.
- Ensure compliance with GCP, ICH, and 21 CFR Part 11 standards.
- Process Improvement
- Contribute to the development and refinement of internal programming standards, macros, and reusable code libraries.




- Identify opportunities to optimize workflows and improve efficiency within the programming team.
- Performs other duties as assigned
- Complies with all policies and standards

Preferred candidate profile

- Bachelor's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Required or
- Master's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Preferred
- 4-6 years as a statistical programmer in a pharmaceutical, biotech, or CRO environment. Required
- Strong programming skills in SAS as Base, Macro, SQL; familiarity with R or Python is a plus. High
- In depth knowledge of CDISC SDTM and ADaM standards. High
- Experience supporting clinical trial reporting and preparing data for regulatory submissions as FDA, EMA. High
- Excellent attention to detail, problem solving, and communication skills. High
- Ability to work independently and collaboratively in a rapid paced environment. High

📌 Senior Statistical Programmer (Bengaluru)
🏢 Emmes
📍 Bengaluru