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Senior Stat Programmer

5-8 years
Not Disclosed
10 Nov. 28, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Stat Programmer – Remote (India)

Job ID: 25103313
Updated: November 13, 2025
Location: IND – Remote
Employment Type: Full-Time

About the Role

The Senior Stat Programmer will support global clinical development projects by creating high-quality statistical programming deliverables. This position requires expertise in SAS programming, clinical trial data standards, and cross-functional collaboration. The role is critical in ensuring accurate, compliant, and inspection-ready statistical outputs that support regulatory submissions and clinical decision-making.

This position is part of a leading biopharmaceutical solutions organization known for integrating clinical, medical affairs, and commercial services to accelerate drug development and improve patient outcomes.


Key Responsibilities

  1. Statistical Programming & Analysis

    • Develop custom SAS or other programming code to create tables, listings, figures, and derived datasets based on the Statistical Analysis Plan and programming specifications.

    • Perform validation programming and ensure all outputs meet quality and regulatory standards.

  2. Quality Control & Compliance

    • Maintain complete and audit-ready documentation, verification records, and programming specifications.

    • Adhere to SOPs, Work Instructions, and ICH guidelines throughout all project activities.

  3. Project Coordination & Delivery

    • Manage timelines across multiple concurrent studies.

    • Provide accurate time estimates, adjust work priorities as required, and ensure timely delivery of programming tasks.

  4. Technical Leadership

    • Serve as the Lead Statistical Programmer on assigned studies.

    • Review SAPs, mock shells, CRFs, programming specs, and dataset designs to ensure smooth project execution.

    • Collaborate with Biostatisticians and cross-functional teams to resolve discrepancies and enhance efficiency.

  5. Team Contribution & Collaboration

    • Participate in sponsor meetings, internal study meetings, and bid-defense presentations.

    • Mentor junior programmers, contribute to training development, and support knowledge-sharing initiatives.

  6. Documentation & Communication

    • Provide progress updates to stakeholders and communicate issues requiring attention.

    • Facilitate structured and effective meetings with clear follow-up actions.


Required Experience & Qualifications

1. Education

  • Bachelor’s degree in Statistics, Computer Science, Life Sciences, or a related discipline.

  • Equivalent experience will be considered in lieu of formal education.

2. Experience Level

  1. Minimum 5–8 years of hands-on experience in statistical programming.

  2. Extensive experience working with SAS or equivalent programming tools in a clinical trial environment.

  3. Experience handling SDTM/ADaM datasets, TLF generation, and regulatory submission standards.

3. Technical Skills

  • Advanced SAS programming expertise.

  • Strong understanding of clinical data structures, CDISC standards, and regulatory requirements.

  • Ability to troubleshoot and optimize programming workflows.

4. Soft Skills

  • Excellent spoken and written English communication skills.

  • Ability to manage multiple priorities, work independently, and collaborate within diverse global teams.


Why Join This Organization

  • Strong focus on employee development, career growth, and continuous training.

  • Supportive work environment promoting authenticity, inclusion, and collaboration.

  • Opportunity to contribute to global studies working across 110 countries with a workforce of over 29,000 professionals.

  • High-impact role supporting projects that have contributed to FDA and EMA approvals worldwide.


Additional Information

  • Minimal travel may be required.

  • Responsibilities listed are not exhaustive; additional duties may be assigned.

  • Reasonable accommodations are provided in alignment with applicable regulations.


Summary

The Senior Stat Programmer plays a pivotal role in developing reliable statistical programming solutions for global clinical studies. The position demands strong technical expertise, leadership skills, and the ability to produce regulatory-compliant programming deliverables. This role supports critical decision-making across clinical development and contributes directly to improving patient outcomes globally.