Senior Statistical Programmer

Emmes Group; Bengaluru; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Emmes Group in Bengaluru, India is seeking a Senior Statistical Programmer to develop and validate SDTM/ADaM datasets in CDISC standards. You will create Tables, Listings, and Figures for CSRs and regulatory submissions, translating SAPs into robust code.

The role requires 4–6 years in the field, strong SAS skills (Base/Macro/SQL) with R or Python a plus, and the ability to work both independently and with cross-functional teams in a fast-paced environment.

Qualifications

• Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field (required).
• Master's Degree preferred in the same domains.
• 4-6 years as a statistical programmer in pharma/biotech/CRO (required).
• Strong programming skills in SAS (Base, Macro, SQL); familiarity with R or Python is a plus.
• Deep knowledge of CDISC SDTM and ADaM standards.
• Experience supporting clinical trial reporting and data preparation for regulatory submissions (FDA, EMA).
• Excellent attention to detail, problem-solving, and communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Responsibilities

• Program, validate SDTM/ADaM datasets per CDISC standards.
• Develop, test, and validate TLFs for CSRs and regulatory submissions.
• Translate SAPs into efficient code.
• Serve as lead programmer on studies within a program.
• Collaborate with Biostatisticians, Clinical Data Managers, and Regulatory staff.
• Ensure timely and accurate delivery of programming outputs per timelines.
• Conduct independent quality checks and maintain programming docs per SOPs and regulatory guidelines.
• Ensure compliance with GCP, ICH, and 21 CFR Part 11.
• Identify opportunities to optimize workflows and reusable code libraries.
• Performs other duties and adhere to all policies.

Skills

SAS

Base SAS

Macro SAS

SQL

R

Python

Education

Bachelor's Degree Computer Science/Statistics/Life Sciences

Master's Degree Computer Science/Statistics/Life Sciences

Job description

Be Part of One Team, One Purpose.
At

cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.
Through our two business units—

Overview

Senior Statistical Programmer

Be Part of One Team, One Purpose.

At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.

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

Qualifications

• 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 fast paced environment. High

If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.