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Statistical Programmer

ICON
5+ years
₹15–24 LPA
Bangalore, Remote, India, India
15 July 7, 2026
Job Description
Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Statistical Programmer

Company: ICON plc
Location: Bangalore, India
Work Mode: Office with Flex (Hybrid)
Department: Biostatistics & Statistical Programming
Employment Type: Full-Time

Experience: 5+ years of experience in Statistical Programming within the Clinical Research or CRO industry, with expertise in SAS, R, Python, clinical trial data analysis, and regulatory reporting.
Salary Package: ₹15–24 LPA (Approx., based on current market standards; final compensation depends on candidate experience, programming expertise, and clinical trial exposure.)


Role Overview

The Statistical Programmer is responsible for developing, validating, and maintaining statistical programs to support clinical trial analysis, regulatory submissions, and reporting. The role collaborates closely with Biostatistics and cross-functional teams to ensure high-quality programming deliverables, regulatory compliance, and accurate interpretation of clinical trial data.


Key Responsibilities

Statistical Programming

  • Develop, validate, and maintain statistical programs using:

    • SAS

    • R

    • Python

    • R Shiny (preferred)

  • Perform data manipulation, statistical analysis, and reporting for clinical trials.

  • Create and validate derived datasets to support statistical analyses.

  • Ensure programming deliverables are accurate, efficient, and completed within project timelines.


Clinical Trial Data Analysis

  • Collaborate with Biostatisticians to interpret study protocols and statistical requirements.

  • Implement statistical analyses based on approved Statistical Analysis Plans (SAPs).

  • Generate and validate:

    • Tables

    • Listings

    • Figures (TLFs)

    • Analysis datasets

  • Review statistical outputs for quality, consistency, and regulatory compliance.


Regulatory Compliance & Documentation

  • Prepare and review:

    • Statistical Analysis Plans (SAPs)

    • Programming specifications

    • Derived datasets

    • Validation documentation

  • Ensure compliance with:

    • ICH-GCP Guidelines

    • Regulatory requirements

    • CDISC standards (SDTM/ADaM preferred)

    • Company SOPs

  • Maintain high standards of data integrity throughout the programming lifecycle.


Cross-Functional Collaboration

  • Work closely with:

    • Biostatistics

    • Clinical Data Management

    • Clinical Operations

    • Medical Writing

    • Regulatory Affairs

  • Participate in project meetings and provide statistical programming expertise.

  • Support regulatory submissions with accurate statistical outputs.

  • Communicate technical concepts effectively to cross-functional stakeholders.


Mentoring & Continuous Improvement

  • Mentor and support junior Statistical Programmers.

  • Provide guidance on programming standards, validation techniques, and best practices.

  • Assist in training new team members.

  • Contribute to process improvement and programming standardization initiatives.


Educational Qualification

  • Bachelor's degree in:

    • Statistics

    • Mathematics

    • Computer Science

    • Data Science

    • Or another related discipline

Preferred: Master's degree or other advanced qualification in a relevant field.


Required Experience

  • 5+ years of Statistical Programming experience within the Clinical Research, Pharmaceutical, Biotechnology, or CRO industry.

  • Experience supporting global clinical trials and regulatory submissions.

  • Strong knowledge of statistical methodologies and programming standards.

  • Experience working with clinical data management systems.


Technical Skills

  • Advanced proficiency in:

    • SAS

    • R

    • Python

    • R Shiny (preferred)

  • Experience with:

    • Statistical Analysis Plans (SAPs)

    • Clinical trial datasets

    • Derived datasets

    • Tables, Listings & Figures (TLFs)

    • Clinical data validation

  • Knowledge of CDISC standards (SDTM and ADaM) is preferred.

  • Good understanding of ICH-GCP guidelines and global regulatory requirements.

  • Proficiency in Microsoft Office applications.


Key Competencies

  • Strong analytical and statistical problem-solving skills.

  • Excellent programming and validation abilities.

  • High attention to detail and data accuracy.

  • Strong communication and collaboration skills.

  • Ability to work independently and manage multiple projects simultaneously.

  • Leadership and mentoring capabilities.

  • Strong organizational and time management skills.

  • Commitment to quality, compliance, and continuous process improvement.