Statistical Programmer

Location: Mumbai / Pune / Bangalore / Noida
Experience: Minimum 2+ years of experience in SAS Programming
Shift: General Shift

Job Overview

We are looking for an experienced Statistical Programmer to lead statistical programming activities across clinical development projects. The ideal candidate should have strong expertise in SAS programming, CDISC standards, ADaM, TFLs, and clinical study processes, along with experience in team leadership and regulatory submissions.

Educational Qualification

• Graduation is compulsory.

• Preferred: Life Science, Computer Science, or Statistics graduate.

• Candidates with relevant statistical programming experience are preferred.

Required Skills

• SAS Programming

• R Programming

• CDISC Standards

• ADaM

• Tables, Listings & Figures (TFL)

• Clinical Data Analysis

• Statistical Programming

• Regulatory Submissions

• SAS Macros

• Clinical Study Lifecycle

• Team Leadership

• Cross-functional Collaboration

Key Responsibilities

• Lead statistical programming activities for assigned compounds, indications, or therapeutic areas.

• Lead and mentor a team of Statistical Programmers and manage resource planning.

• Develop and oversee SAS programs for ADaM datasets in accordance with CDISC standards.

• Develop and oversee Tables, Listings, and Figures (TFLs).

• Ensure quality, consistency, and timely delivery of project programming activities.

• Ensure consistency of ADaM datasets across individual studies and integrated datasets.

• Prepare documentation required for regulatory filings, including reviewer guides and data definition documents.

• Develop standard SAS macros and contribute to standard operating procedures.

• Provide technical oversight and mentoring to Statistical Programmers, Statistical Analysts, and Senior Statistical Analysts.

• Collaborate effectively with Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing, and Clinical Operations teams.

• Estimate effort and resources required for programming activities and manage changing priorities and deadlines.

Preferred Experience

• Minimum 2+ years of SAS programming experience.

• Experience leading statistical programming activities for clinical studies.

• Experience in therapeutic areas such as Oncology, Immunology, Neuroscience, etc.

• Hands-on experience with SAS/R for ADaM, TFL, and statistical analyses.

• Experience with regulatory filings is preferred.

Important Requirements

• Graduation is mandatory.

• Former TCS employees/rehires will not be considered.

• PAN and DOB are required for employee profile creation in the database.

• Profiles should include a percentage match score against the role requirements.