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Manager – Statistical Programming

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ICON
8-12 years
Not Disclosed
Bangalore, Chennai, Trivandrum, India
2 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology

Manager – Statistical Programming

Location: Bangalore, India / Chennai, India / Trivandrum, India
Work Mode: Office With Flex
Job Type: Full-Time
Experience Required: Minimum 8–12+ Years in Statistical Programming or Clinical Data Programming
Industry: Clinical Research / Pharmaceutical / CRO / Biostatistics


Job Overview

We are seeking an experienced and results-driven Manager – Statistical Programming to lead statistical programming activities for global clinical trials. The selected candidate will oversee the development, validation, and delivery of statistical programming outputs while managing a team of programmers and collaborating with cross-functional clinical research teams.

This role is ideal for professionals with strong expertise in SAS programming, statistical analysis, clinical trial data processing, and regulatory compliance within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

Statistical Programming Leadership

  • Lead and manage day-to-day statistical programming activities across multiple clinical studies.
  • Oversee development and validation of:
    • Statistical Analysis Plans (SAPs)
    • Clinical datasets
    • Tables, Listings, and Figures (TLFs)
    • Statistical reports
  • Ensure programming deliverables meet:
    • Study timelines
    • Quality standards
    • Regulatory requirements
    • Sponsor expectations

Clinical Trial Data Programming

  • Manage programming activities related to:
    • Clinical trial datasets
    • Data transformations
    • Statistical outputs
    • Clinical reporting
  • Support analysis and reporting activities throughout the clinical trial lifecycle.
  • Ensure compliance with:
    • CDISC standards
    • SDTM standards
    • ADaM standards
    • Regulatory guidelines

Team Management & Mentorship

  • Lead and mentor a team of statistical programmers.
  • Foster a collaborative and high-performance work culture.
  • Support:
    • Team development
    • Technical training
    • Performance management
    • Knowledge sharing initiatives
  • Guide junior programmers on programming standards and best practices.

Cross-Functional Collaboration

  • Collaborate closely with:
    • Biostatisticians
    • Clinical Data Management teams
    • Clinical Operations
    • Regulatory Affairs teams
    • Sponsors and stakeholders
  • Ensure programming activities align with:
    • Study objectives
    • Project timelines
    • Statistical methodologies
    • Clinical development goals

Validation & Quality Compliance

  • Review and validate programming outputs to ensure:
    • Accuracy
    • Data integrity
    • Regulatory compliance
    • Statistical consistency
  • Implement quality control processes and programming best practices.
  • Ensure adherence to:
    • ICH-GCP guidelines
    • Industry standards
    • Internal SOPs
    • Sponsor requirements

Process Improvement & Innovation

  • Stay updated with:
    • Statistical programming technologies
    • Industry best practices
    • Automation tools
    • Clinical data standards
  • Drive continuous improvement initiatives to enhance:
    • Programming efficiency
    • Data quality
    • Workflow optimization
    • Team productivity

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree in:
    • Statistics
    • Computer Science
    • Mathematics
    • Data Science
    • Biostatistics
    • Or related disciplines

Preferred Qualification

  • Master’s Degree preferred in:
    • Statistics
    • Biostatistics
    • Data Analytics
    • Computer Science
    • Healthcare Analytics