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Manager 1 – Statistical Programming

Sun Pharma
Sun Pharma
8+ years
preferred by company
Gurgaon, India
1 May 14, 2026
Job Description
Job Type: Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment

Manager 1 – Statistical Programming

Location: Gurgaon, Haryana, India / Remote / Hybrid
Employment Type: Full-Time
Department: Global Clinical Development / Statistical Programming / Clinical Data Sciences
Experience Required: 8+ Years


Job Overview

An excellent leadership opportunity is available for an experienced Manager 1 – Statistical Programming within the global clinical development and biostatistics domain. This role is ideal for professionals with strong expertise in clinical statistical programming, SAS programming, CDISC implementation, regulatory submissions, clinical trial data standards, and programming leadership.

The selected candidate will lead and support statistical programming activities across multiple clinical development programs, ensuring high-quality, compliant, and timely programming deliverables for ongoing clinical studies, regulatory submissions, study reporting, and advanced analysis requirements.

This role is ideal for experienced professionals seeking career growth in clinical statistical programming, regulatory programming, biostatistics operations, clinical data standards, and pharmaceutical R&D leadership.


Key Responsibilities

Statistical Programming Leadership

  • Lead statistical programming activities across therapeutic areas, compounds, and multi-study development programs
  • Ensure timely and high-quality delivery of programming outputs aligned with project strategies
  • Drive programming execution according to organizational standards, study requirements, and regulatory expectations
  • Support complex programming deliverables across global clinical development programs

Clinical Data Standards & Programming Documentation

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

SAS Programming & Clinical Reporting

  • Develop and oversee SAS programs for:
    • SDTM datasets
    • ADaM datasets
    • Tables
    • Listings
    • Figures (TLFs)
    • Study reports
    • Ad hoc analyses
    • Post hoc analyses
  • Maintain programming quality, consistency, and validation standards

Regulatory Submission Support
Support global regulatory submission deliverables for agencies including:

  • FDA
  • EMA
  • PMDA
  • Other international health authorities

Handle submission-related deliverables such as:

  • P21 validation activities
  • eCRT packages
  • aCRF
  • define.xml
  • cSDRG
  • ADRG
  • ARM
  • eCTD support documentation

Collaborate with regulatory and cross-functional teams to address health authority queries.

Clinical Study Collaboration

  • Participate in:
    • CRF annotation
    • SAP review
    • TLF specification development
    • TLF quality review
  • Work closely with:
    • Biostatistics teams
    • Clinical data management
    • Regulatory teams
    • Medical writing
    • External service providers
    • Clinical operations stakeholders

Process Improvement & Standards Development

  • Contribute to:
    • SOP development
    • Standard macro creation
    • Statistical programming standards
    • SME initiatives
    • Training programs
    • Process optimization efforts

Team Leadership & Mentorship

  • Mentor and coach junior programmers and new hires
  • Provide technical guidance on complex programming tasks
  • Support team capability development and quality excellence
  • Foster collaboration, accountability, and continuous learning

Required Qualifications

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

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

Advanced qualifications will be advantageous.