Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Manager 2 – Statistical Programming

Sun Pharma
Sun Pharma
10+ years
preferred by company
Gurgaon, Remote, India, India
1 May 14, 2026
Job Description
Job Type: Hybrid Education: B.Pharm/M.Pharm/M.Sc.or equivalent in life sciences Skills: Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines

 

Manager 2 – Statistical Programming

Location: Gurgaon, Haryana, India / Remote / Hybrid
Employment Type: Full-Time
Department: Global Clinical Development / Statistical Programming / Clinical Data Sciences
Experience Required: 10+ Years (Estimated based on role seniority and responsibilities)


Job Overview

An advanced leadership opportunity is available for an experienced Manager 2 – Statistical Programming within the global clinical development and pharmaceutical research domain. This role is ideal for senior statistical programming professionals with strong expertise in clinical trial programming, SAS programming, CDISC implementation, regulatory submission programming, Phase I–IV clinical studies, and cross-functional technical leadership.

The selected candidate will lead statistical programming activities across multiple clinical studies and therapeutic programs, ensuring timely delivery of high-quality programming outputs supporting clinical development, study reporting, global regulatory submissions, and advanced analytical requests.

This position is highly suitable for professionals seeking career advancement in clinical statistical programming leadership, regulatory programming, pharmaceutical R&D analytics, clinical data standards governance, and biostatistics operations management.


Key Responsibilities

Statistical Programming Leadership

  • Lead end-to-end statistical programming activities across Phase I to Phase IV clinical studies
  • Manage programming deliverables across therapeutic areas, compounds, and multi-study development programs
  • Ensure delivery of accurate, compliant, and timely programming outputs aligned with project strategy
  • Function as a technical lead, SME, and collaborative programming leader

Clinical Data Standards & Programming Governance

  • Develop and maintain programming documentation aligned with internal standards and industry best practices
  • Create and review:
    • SDTM mapping specifications
    • ADaM specifications
    • Programming documentation
    • Validation plans
    • Study deliverables documentation
  • Ensure strict implementation of CDISC standards, TAUG guidance, and regulatory requirements

SAS Programming & Clinical Reporting

  • Develop and oversee SAS programs for:
    • SDTM datasets
    • ADaM datasets
    • Tables
    • Listings
    • Figures (TLFs)
    • Study reporting
    • Ad hoc analysis
    • Post hoc analysis
  • Maintain programming quality control and validation excellence

Regulatory Submission Support
Lead programming support for global regulatory submissions to:

  • FDA
  • EMA
  • PMDA
  • Other international health authorities

Manage submission deliverables including:

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

Support health authority responses in collaboration with regulatory and clinical teams.

Clinical Development Collaboration

  • Participate in:
    • CRF annotation
    • Statistical Analysis Plan (SAP) review
    • TLF specification development
    • TLF review
  • Collaborate with:
    • Biostatistics
    • Clinical data management
    • Regulatory affairs
    • Clinical operations
    • Medical writing
    • External service providers
    • Cross-functional global teams

Standards Development & Process Excellence

  • Contribute to:
    • Standard macro development
    • Utility macro creation
    • Statistical programming process improvement
    • Library standardization
    • SME initiatives
    • Technical governance
  • Support department-wide programming quality initiatives

Mentorship & Team Leadership

  • Mentor and coach junior programmers and new hires
  • Provide technical guidance across complex programming tasks
  • Support capability building and programming excellence
  • Foster a collaborative, performance-driven environment

Required Qualifications

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

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

Advanced academic qualifications will be advantageous.


Required Skills & Competencies

  • Advanced SAS programming expertise
  • Clinical statistical programming leadership
  • CDISC implementation
  • SDTM programming
  • ADaM dataset programming
  • TLF generation
  • Regulatory submission programming
  • Pinnacle 21 validation
  • Clinical trial data processing
  • SAP interpretation
  • Programming standards governance
  • Cross-functional collaboration
  • Team mentoring
  • Strong analytical problem-solving
  • Stakeholder communication and project coordination
  • Ability to manage fast-paced complex deliverables