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Join the HireLink Pvt. Ltd team as a Full Time Senior Statistical Programmer on Erekrut, specializing in Senior Statistical Programmer in the Healthcare industry. We are seeking talented individuals with a passion for IT Services and educational qualifications ranging from 7-10 Years.

Apply now on Erekrut to take the next step in your career with a leading global company.

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
- Robust 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

ADaM Dataset DevelopmentAdvanced R ProgrammingAdvanced Statistical AnalysisAnalysis Dataset ValidationAnalytical ThinkingAutomation & Reusable Code DevelopmentCDISC ComplianceClinical Data AnalysisClinical Data Management InteractionClinical Study Reports (CSR)Clinical Trial ProgrammingClinical Trial ReportingCross-functional CollaborationData Integrity & Audit ReadinessData ValidationDerived Variable ProgrammingEnd-to-End Statistical ProgrammingFDA / EMA Submission SupportGxP Compliance KnowledgeISS / ISE Programming

Industry

Healthcare

Functional Area

IT Services

Employment Type

Full Time

Education

Graduation/Diploma

Job Type

Work From Office

📌 Senior Statistical Programmer (Karnataka)
🏢 hirelink
📍 Karnataka