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Senior Manager 1 – Statistical Programming

Sun Pharma
Sun Pharma
12+ years
preferred by company
Gurgaon, India
1 May 14, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Senior Manager 1 – Statistical Programming

Location: Gurgaon, Haryana, India
Employment Type: Full-Time
Department: Clinical Research & Development / Biostatistics / Statistical Programming
Experience Required: 12+ Years
Company Sector: Pharmaceutical Research & Development


Job Overview

A senior leadership opportunity is available for an experienced Senior Manager 1 – Statistical Programming within the pharmaceutical clinical research and development domain. This role is ideal for seasoned professionals with expertise in clinical statistical programming, SAS programming, CDISC implementation, regulatory submissions, clinical trial data standards, and programming team leadership.

The selected candidate will lead statistical programming strategy and execution across multiple clinical studies, ensuring timely, high-quality programming deliverables supporting clinical development, regulatory submissions, study reporting, and advanced analytical requirements.

This is a strategic role suited for professionals seeking advancement in biostatistics programming leadership, clinical data standards, regulatory programming, global submission support, and clinical analytics management.


Key Responsibilities

Statistical Programming Leadership

  • Lead statistical programming activities across therapeutic areas, compounds, and multi-study clinical programs
  • Oversee end-to-end programming deliverables to ensure quality, compliance, and timely execution
  • Drive programming strategy aligned with study objectives and organizational standards
  • Provide technical and operational leadership for statistical programming teams

Clinical Data Programming & Standards

  • Develop and maintain programming documentation following internal standards and industry best practices
  • Create and review:
    • SDTM mapping specifications
    • ADaM specifications
    • Programming documentation
    • Validation deliverables
  • Ensure implementation of CDISC standards across study programs

SAS Programming & Deliverables

  • Develop and oversee SAS programs for:
    • SDTM datasets
    • ADaM datasets
    • Tables
    • Listings
    • Figures (TLFs)
    • Study reporting outputs
    • Post-hoc and ad hoc analyses
  • Ensure programming deliverables meet regulatory submission requirements

Regulatory Submission Support
Lead programming support for global regulatory submissions, including:

  • FDA submissions
  • EMA submissions
  • PMDA submissions
  • Other international regulatory authorities

Support preparation of:

  • eCRT packages
  • aCRF
  • define.xml
  • cSDRG
  • ADRG
  • ARM documentation
  • eCTD submission deliverables

Handle Pinnacle 21 (P21) compliance and validation-related activities.

Clinical Study Collaboration

  • Partner closely with:
    • Biostatistics teams
    • Clinical data management
    • Regulatory affairs
    • Medical writing
    • Clinical operations
    • External service providers
  • Support CRF annotation, SAP review, and TLF specification development
  • Address health authority queries and submission-related requests

Standards, Innovation & Process Improvement

  • Contribute to:
    • Statistical programming SOPs
    • Standard macro development
    • Department process improvements
    • Subject Matter Expert (SME) initiatives
    • Training guidelines
  • Provide technical leadership on evolving CDISC and regulatory standards

People Management & Mentorship

  • Lead, mentor, and develop junior programmers and new team members
  • Foster a collaborative, high-performance programming environment
  • Support capability development, quality improvement, and operational excellence
  • Balance technical leadership with people management responsibilities

Required Qualifications

Educational Qualifications
Candidates must hold a Bachelor’s Degree or higher in one of the following:

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

Advanced degrees will be considered advantageous.