Statistical Programmer II

eClinical Solutions LLC; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

eClinical Solutions LLC in Bengaluru seeks an experienced Statistical Programmer to support multiple clinical studies by delivering SDTM/ADaM datasets, TLFs, and submission-ready outputs.

Proficiency in SAS (Base, SAS/STAT, Macro), R, and CDISC standards is required; familiarity with AI-assisted programming is a plus.

You will develop specifications, MSAs, QC macros, and collaborate with cross-functional teams to ensure regulatory compliance and timely deliverables.

Qualifications

• BSc or MSc in science/health fields; statistics preferred.
• SAS Certified is required.
• R programming experience is a plus.
• Strong English communication, both written and verbal.

Responsibilities

• Develop specifications and SAS programs for SDTM datasets and clinical analyses.
• Create specifications and SAS programs for ADaM datasets for trial reporting.
• Develop, maintain, and validate Tables, Listings, and Graphs (TLGs).
• Program and QC data listings, summaries, graphs, and models.
• Design and maintain reusable SAS macros for Phase I–IV reporting.
• Generate submission-ready datasets and outputs per regulatory standards.
• Collaborate with cross-functional teams to ensure timely delivery of high-quality outputs.
• Maintain project documentation in compliance with SOPs and regulatory expectations.
• Independently write R programs and convert SAS programs to R using AI tools.

Skills

English communication

Independent problem solving

Cross-functional collaboration

Attention to detail

Time management

Education

Bachelor of Science

Master in Statistics

SAS Certified

R programming

Tools

Base SAS

SAS/STAT

Macro Language

PROC SQL

SAS/GRAPH

SAS/CONNECT

SAS/ACCESS

R programming

Git version control

Job description

OVERVIEW

Experienced Statistical Programmer with expertise in supporting multiple clinical studies through the development, validation, and delivery of high‑quality statistical programming outputs. Proficient in SAS (Base SAS, SAS/STAT, and Macro Language) and CDISC standards, including SDTM, ADaM, and TLF development for regulatory submissions. Skilled in creating analysis datasets, safety and efficacy tables, listings, figures, Define.xml, and submission packages compliant with FDA, PMDA, and EMA requirements. Strong knowledge of the clinical drug development process, data automation, safety reporting, DSUR/PSUR deliverables, and Pinnacle 21 validation. Proven ability to collaborate with internal stakeholders, proactively resolve programming issues, and ensure timely, compliant, and accurate study deliverables. Use of R and AI tools to augment, enhance day to day programming is a huge plus.

KEY TASKS & RESPONSIBILITIES

• Develop specifications and SAS programs for SDTM datasets and clinical data analysis deliverables.
• Create specifications and SAS programs for ADaM datasets supporting trial‑level reporting and integratedsafety and efficacy analyses.
• Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirementsand Statistical Analysis Plans (SAPs).
• Program and QC data listings, summaries, graphs, and statistical models as required.
• Design and maintain reusable SAS macros to support Phase I–IV clinical trial reporting.
• Generate submission‑ready datasets and output using industry standards, SDLC practices, and regulatory requirements.
• Collaborate with cross‑functional teams to ensure timely delivery of high‑quality study outputs.
• Maintain project documentation in compliance with SOPs, processes, and quality standards.
• Ensure adherence to eClinical Solutions and industry guidelines, procedures, and regulatory expectations.
• Ability to independently write R programs and convert SAS programs to R programs using AI tools to create datasets and TLFs.

Education & Experience

• Basic Science/Bachelor of Science degree (Master in Statistics or related science preferred) in health‑related fields, computer science or equivalent experience preferred.
• SAS Certified
• R programming experience is a plus
• Knowledge and experience in using AI to gain programming efficiencies is a plus
• Excellent written and verbal communication skills in English

Professional Skills

• Minimum 4‑5 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred.
• Strong experience in preparations for NDA filings
• Strong knowledge of E6, E3, E9 guidelines, 21 CFR Part 11 and clinical trial methodologies
• Knowledge of coding dictionaries (WHO, COSTART, ICD‑9, MedDRA)
• Knowledge of CDISC related data models like SDTM, and ADAM.
• Experience of working on multiple clinical protocols at the same time.
• Excellent verbal and written communication skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.
• Excellent team player

Technical Skills

• Advanced SAS programming expertise in data extraction, integration, analysis, reporting, and automation.
• Proficient in Base SAS, PROC SQL, Macro Programming, ODS, SAS/GRAPH, SAS/STAT, SAS/CONNECT, and SAS/ACCESS.
• Extensive experience with SAS reporting procedures, including PROC SQL, PROC REPORT, PROC SUMMARY / PROC Means, PROC FREQ, and PROC TRANSPOSE, in clinical research environments.
• Skilled in working with relational databases, SAS performance optimization, and process automation through batch, shell scripting and AI tools.
• Experienced in R programming (tidyverse, dplyr, admiral, rtables ggplot2, xportr, flextable) and Git‑based version control (GitHub, GitLab).
• Experienced in developing Tables, Listings, and Graphs (TLGs) using SAS and R for clinical trial analysis and reporting.