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Senior Executive – Statistical Programming

Sun Pharma
Sun Pharma
3-6 years
preferred by company
Gurgaon, Remote, India, India
1 May 14, 2026
Job Description
Job Type: Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines

Senior Executive – Statistical Programming

Location: Gurgaon, Haryana, India / Remote / Hybrid
Employment Type: Full-Time
Department: Global Clinical Development / Statistical Programming / Clinical Data Sciences
Experience Required: 3–6+ Years (Estimated based on role scope and responsibilities)


Job Overview

An exciting opportunity is available for a Senior Executive – Statistical Programming within the pharmaceutical clinical development and biostatistics domain. This role is ideal for professionals with strong expertise in SAS programming, clinical trial data processing, CDISC implementation, regulatory submission support, statistical programming, and clinical reporting.

The selected candidate will support end-to-end statistical programming activities across Phase I–IV clinical studies, contributing to high-quality programming deliverables for clinical development, study reporting, global regulatory submissions, and ad hoc analytical requests.

This role is an excellent fit for professionals looking to advance their careers in clinical statistical programming, pharmaceutical data sciences, biostatistics programming, and regulatory data submission support.


Key Responsibilities

Statistical Programming Support

  • Support statistical programming activities across therapeutic areas, compounds, and multi-study clinical programs
  • Deliver timely, accurate, and high-quality programming outputs aligned with project strategies
  • Collaborate with programming leads and study teams to support end-to-end study deliverables
  • Contribute to execution of statistical programming standards and quality processes

Clinical Data Programming

  • Update and maintain programming documentation aligned with organizational and industry standards
  • Support development and maintenance of:
    • SDTM mapping specifications
    • ADaM specifications
    • Programming documentation
    • Validation outputs
  • Ensure implementation of CDISC standards across study deliverables

SAS Programming & Clinical Reporting

  • Develop and validate SAS programs for:
    • SDTM datasets
    • ADaM datasets
    • Tables
    • Listings
    • Figures (TLFs)
    • Study reporting outputs
    • Ad hoc analyses
    • Post hoc analyses
  • Support programming quality control and validation activities

Regulatory Submission Support
Contribute to programming deliverables for submissions to:

  • FDA
  • EMA
  • PMDA
  • Other global regulatory authorities

Support submission documentation including:

  • Pinnacle 21 (P21) validation
  • eCRT packages
  • aCRF
  • define.xml
  • cSDRG
  • ADRG
  • ARM
  • eCTD-related submission deliverables

Collaborate with internal teams to support health authority responses.

Clinical Study Collaboration

  • Participate in:
    • CRF annotation
    • TLF specification development
    • Macro development
    • Clinical programming review activities
  • Work with:
    • Project Technical Leads (PTLs)
    • Biostatistics teams
    • Clinical data management
    • Regulatory teams
    • External vendors
    • Global study stakeholders

Standards & Process Contribution

  • Contribute to:
    • Utility macro development
    • Statistical programming standards
    • Process improvements
    • Quality initiatives
  • Support continuous improvement within programming operations

Required Qualifications

Educational Qualifications
Candidates should hold a Bachelor’s Degree or higher in:

  • Statistics
  • Computer Science
  • Mathematics
  • Engineering
  • Life Sciences
  • Biostatistics
  • Related technical or scientific disciplines