Senior Statistical Programmer
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Job Description
Job Title: Statistical / Senior Statistical Programmer
Location: Remote
Work Schedule: General Shift | 5 Days a Week
Joining: Immediate or within 30 Days
Compensation: Up to ₹25 LPA (can go up to ₹30 LPA based on experience)
Job Summary
We are seeking an experienced Statistical / Senior Statistical Programmer to support end-to-end clinical trial programming activities. The ideal candidate will have strong hands-on experience in statistical programming, regulatory submissions, and advanced analysis datasets, with a particular focus on SAS and R programming, ADaM datasets, and TLF deliverables.
Qualifications
- Bachelor’s or Master’s degree in:
- Pharmacy (B.Pharm / M.Pharm), OR
- Life Sciences (BSc / MSc), OR
- Engineering (BTech / MTech) with Life Sciences, Biotechnology, Biomedical, or related background
Experience Requirements
- 6+ years of experience as a Statistical Programmer
- Strong hands-on experience with SAS programming
- Minimum 2 years of hands-on R programming experience (mandatory)
- Only R knowledge or certification without hands-on experience will not be acceptable
- Experience working on healthcare / pharma datasets, including Clinical Research and Clinical Data Management
Key Responsibilities
End-to-End Statistical Programming
- Handle the complete programming lifecycle from raw data to submission-ready outputs
- Convert raw data to SDTM datasets as per CDISC standards
- Create ADaM datasets from SDTM, including derivations, flags, baseline, and treatment groups
- Develop Tables, Listings, and Figures (TLFs)
- Perform validation and QC of datasets and outputs
- Support regulatory submissions
SDTM Programming
- Create SDTM specification documents
- Write programs to generate SDTM datasets
- Convert SDTM datasets into XPT format for validation purposes
- Ensure compliance with CDISC standards
ADaM Programming
- Develop analysis-ready ADaM datasets
- Apply analysis flags and derive parameters
- Follow CDISC ADaM standards
TLF Development
- Generate Tables for efficacy and safety summaries
- Create Listings for patient-level data
- Develop Figures including graphs and plots
- Support Clinical Study Reports (CSR)
Regulatory Submission Support
- Support ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy)
- Assist in NDA / BLA submissions
- Respond to Regulatory Authority Queries (RTQs)
R Programming
- Write optimized R code for clinical data analysis
- Use R packages including dplyr, plyr, ggplot2, tidyverse, shiny
- Create production-level statistical programs
- Generate publication-quality graphs
- Work with large clinical datasets
- Perform data cleaning, analysis, and TLF generation
Collaboration & Quality
- Collaborate with statisticians, clinical data management, and clinical teams
- Ensure deliverables meet quality standards, timelines, and regulatory requirements
- Contribute to process improvements, documentation, and programming standards
Key Skills
- SAS Programming
- SDTM (CDISC Standards)
- ADaM Dataset Development
- TLF Programming (Tables, Listings, Figures)
- End-to-End Statistical Programming
- Regulatory Submissions
- ISS / ISE
- RTQ Handling
- Clinical Study Reports (CSR)
- R Programming
- dplyr
- plyr
- ggplot2
- tidyverse
- shiny
- Clinical Data Analysis
- Clinical Research Programming
- Data Validation & QC
- Cross-functional Collaboration
Designation
Senior Statistical Programmer
Key Skills
Industry
Healthcare
Functional Area
IT Services
Employment Type
Full Time
Education
Graduation/Diploma
Job Type
Work From Office
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