Senior Statistical Programmer

Emmes; India; On-site; INR 1,500,000 - 3,500,000; Full time

Job summary

Emmes Group is seeking a Senior Statistical Programmer to join our team in India. You will develop and validate SDTM/ADaM datasets and create TLFs for CSRs and regulatory submissions, working closely with biostatistics and data management.

The role requires strong SAS skills, CDISC SDTM/ADaM knowledge, and experience in regulated environments. You will contribute to continuous process improvements and ensure 21 CFR Part 11 compliance.

Qualifications

• Bachelor’s or Master’s in a relevant field.
• 4–6 years of statistical programming in pharma/biotech/CRO.
• Strong SAS programming proficiency and CDISC SDTM/ADaM knowledge.
• Experience supporting regulatory submissions (FDA/EMA).
• Attention to detail, problem-solving, and communication.
• Ability to work independently and in teams.

Responsibilities

• Program and validate SDTM/ADaM datasets per CDISC standards.
• Develop Tables, Listings, and Figures for CSR and submissions.
• Translate SAPs into efficient programming code.
• Lead programming on studies or programs and collaborate with Biostatistics and Data Management.
• Ensure quality checks and maintain documentation per SOPs and 21 CFR Part 11.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent & collaborative

Communication skills

Education

Bachelor's degree in CS/Statistics/Life sciences

Master's degree preferred

Tools

SAS Base

SAS Macro

SAS SQL

R

Python

Job description

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.

The Senior Statistical Programmer is responsible for programming, validating, and delivering statistical datasets and outputs to support clinical trial analysis and regulatory submissions. Working closely with Biostatistics, Data Management, and Clinical teams, this role contributes to the delivery of high‑quality, CDISC‑compliant datasets and analysis results for Phase I–IV clinical trials. This position requires strong proficiency in SAS programming, a solid understanding of CDISC standards (SDTM and ADaM), and experience working in a regulated environment.

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.