Sr Statistical Programmer - Contractor

Emmess Services; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Emmess Services seeks a Senior Statistical Programmer to program, validate, and deliver CDISC-compliant datasets for Phase I-IV trials, collaborating with Biostatistics, Data Management, and Clinical teams.

You will translate SAPs into code, produce TLFs for CSRs, support regulatory submissions with CDISC standards, and maintain documentation while ensuring GCP, ICH, and Part 11 compliance.

Qualifications

• Bachelor's or Master's degree in CS, stats, math, life sciences, or a related field.
• 4–6 years of statistical programming experience in pharma/biotech/CRO.
• Strong SAS programming (Base, Macro, SQL); R or Python a plus.
• Deep knowledge of CDISC SDTM and ADaM standards.
• Experience with regulatory submissions data packages (FDA, EMA).
• Excellent attention to detail, problem solving, and communication.
• Ability to work independently and in fast-paced teams.

Responsibilities

• Programming, validate, and deliver SDTM/ADaM datasets.
• Create TLFs for CSR and regulatory submissions.
• Translate SAPs into efficient code.
• Lead programmer on studies; collaborate with cross-functional teams.
• Ensure on-time, accurate programming deliverables.
• Perform quality checks and maintain documentation.
• Ensure compliance with GCP, ICH, and 21 CFR Part 11.
• Develop reusable code libraries and optimize workflows.
• Other duties as assigned.

Skills

SAS programming

CDISC SDTM/ADaM

Clinical trial reporting

Attention to detail

Problem solving

Communication skills

Team collaboration

Python or R familiarity

Education

Bachelor's degree in CS/Stats/Math/Life Sciences

Master's degree in CS/Stats/Math/Life Sciences

Job description

Job Summary

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.

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

• Bachelors Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
• Required or Masters 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.
• In-depth knowledge of CDISC SDTM and ADaM standards.
• Experience supporting clinical trial reporting and preparing data for regulatory submissions as FDA, EMA.
• Excellent attention to detail, problem solving, and communication skills.
• Ability to work independently and collaboratively in a fast paced environment.