Statistical Programmer II
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Before you apply
LocationIndia, Bangalore, Karnataka
Typefull-time
SeniorityMid
Experience4–5 yrs
DepartmentBiometrics Services
Company size501–1,000 people
PostedJun 30, 2026 · 4mo ago
Verified live3d ago
At a glanceSummarised by Seekless from the posting.
Basic Science/Bachelor of Science degree in health-related fields, computer science or equivalent experience
SAS Certified
Excellent written and verbal communication skills in English
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
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
Ability to independently write R programs and convert SAS programs to R programs using AI tools to create datasets and TLFs
Master in Statistics or related science preferred
R programming experience is a plus
Knowledge and experience in using AI to gain programming efficiencies is a plus
Minimum 4-5 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred
Skills
SAS
Base SAS
SAS/STAT
Macro Language
PROC SQL
ODS
SAS/GRAPH
SAS/CONNECT
SAS/ACCESS
R
tidyverse
dplyr
admiral
rtables
ggplot2
xportr
flextable
Git
GitHub
GitLab
Pinnacle 21
CDISC
SDTM
ADaM
WHO
COSTART
ICD-9
MedDRA
About the role
OVERVIEWExperienced 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 integrated safety and efficacy analyses.
➢ Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements and 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.