Senior Statistical Programmer - Contractor

Emmes Group

Bengaluru

On-site

INR 1,500,000 - 2,300,000

Full time

25 hours ago
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Job summary

Emmes Group in Bengaluru, India, is seeking a Senior Statistical Programmer to design, validate, and deliver CDISC-compliant datasets and outputs for Phase I–IV trials. The role emphasizes SAS programming, SDTM/ADaM knowledge, and working in a regulated environment.

You will partner with Biostatistics, Data Management, and Regulatory teams to translate SAPs into efficient code, generate Tables, Listings and Figures, and support regulatory submissions. 4–6 years of pharma CRO experience preferred.

Qualifications

  • Bachelor’s or higher in a relevant field.
  • Experience as a statistical programmer in pharma/biotech/CRO environment.

Responsibilities

  • Program and validate SDTM/ADaM datasets per CDISC.
  • Create Tables, Listings, and Figures for CSRs and submissions.
  • Translate SAPs into efficient code and ensure GCP/ICH compliance.

Skills

SAS programming
SDTM & ADaM
SQL
R or Python (plus)
Regulatory submissions

Education

Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences, or related
Master’s Degree (preferred) in Computer Science, Statistics, Mathematics, Life Sciences, or related

Tools

SAS
R
Python
SQL

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. 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.

CONNECT WITH US!

Find us on LinkedIn:/the-emmes-group/

Visit our website:https://www.theemmesgroup.com/

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