Principal Statistical Programmer

Pfizer; Chennai District; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

Pfizer seeks a Principal Statistical Programmer (PSDS) to support clinical studies, projects, and data standards through high-quality statistical programming. This individual contributor role combines hands-on programming with study leadership, stakeholder collaboration, and mentoring responsibilities in a global environment.

The ideal candidate will have 5+ years of SAS programming experience in the pharmaceutical sector, strong CDISC SDTM/ADaM knowledge, and the ability to deliver

Qualifications

• 5+ years of statistical programming in pharma/biotech/regulatory environments.
• Strong SAS experience and understanding of clinical trial data.
• Knowledge of CDISC SDTM/ADaM and ICH guidelines.
• Experience creating submission-ready datasets and TLFs.
• Ability to manage multiple priorities and work independently.
• Excellent communication and stakeholder management.
• Experience in a therapeutic area is preferred.

Responsibilities

• Lead and deliver programming across studies and standards initiatives.
• Develop, validate, and review SDTM/ADaM datasets and TLFs.
• Program with SAS; knowledge of R/Python advantageous.
• Collaborate with statisticians, clinicians, data managers and global teams.
• Maintain documentation, validation, and QC throughout study lifecycle.
• Contribute to standards, automation, and best practices.
• Mentor junior programmers and provide technical guidance.
• Support resource planning and study timelines.

Skills

SAS programming

CDISC (SDTM/ADaM)

Clinical trials

Stakeholder management

Communication

Education

Bachelor's degree in Statistics/CS/Engineering/Pharmacy/Life Sciences/IT; Master's preferred

Tools

R

Python

Job description

About the Role

We are seeking a Principal Statistical Programmer ( PSDS )to support clinical studies, projects, and data standards initiatives through high-quality statistical programming. This individual contributor role combines hands‑on programming expertise with study leadership, stakeholder collaboration, and mentoring responsibilities. The ideal candidate will have strong experience in clinical trials, CDISC standards, and SAS programming, with the ability to deliver accurate, compliant, and timely results in a global environment.

What You'll Do

• Lead and deliver statistical programming activities across studies, projects, and standards initiatives.
• Develop, validate, and review SDTM/ADaM datasets, Tables, Listings, and Figures (TLFs) in accordance with CDISC and regulatory requirements.
• Program and support clinical deliverables using SAS, with exposure to R and/or Python considered an advantage.
• Collaborate with statisticians, clinicians, data managers, and global study teams to ensure milestone achievement.
• Maintain high-quality documentation, validation, and QC processes throughout the study lifecycle.
• Contribute to standards development, process improvements, automation initiatives, and best practices.
• Mentor junior programmers and provide technical guidance where needed.
• Support resource planning, study timelines, and departmental initiatives.

What You'll Bring

• Bachelor's degree in Statistics, Computer Science, Engineering, Pharmacy, Life Sciences, IT, or a related discipline; Master's degree preferred.
• 5+ years of statistical programming experience within the pharmaceutical MNC, biotechnology, CRO, or regulatory environment.
• Strong hands‑on experience with SAS and a solid understanding of clinical trial data and drug development processes.
• Knowledge of CDISC standards (SDTM/ADaM) and regulatory guidelines, including ICH.
• Experience developing and reviewing datasets, TLFs, and submission‑ready deliverables.
• Ability to manage multiple priorities and work independently in a fast‑paced, global environment.
• Strong analytical, problem‑solving, communication, and stakeholder management skills.
• Knowledge of at least one therapeutic area is preferred.

Why Join Us?

• Opportunity to work on innovative clinical development programs.
• Exposure to global teams and cutting‑edge technologies.
• Collaborative environment that supports learning, growth, and career advancement.
• Meaningful contribution to improving patient outcomes through data‑driven insights.