OHL 406724 Statistical Programmer

Writing

# Job Description: Statistical Programmer – Clinical Research / SAS Programming

**Job Code:** 406724\

**Job Title:** Statistical Programmer\

**Domain:** Life Sciences / Clinical Research\

**Experience Required:** Minimum 2+ years of SAS programming experience\

**Salary Range:** ₹9–20 LPA\

**Band:** BPO 3/4/5/6\

**Locations:** Mumbai / Pune / Bangalore / Noida\

**Shift:** General Shift\

**Reporting To:** Delivery Manager

## Job Summary

We are looking for skilled Statistical Programmers with experience in SAS programming, clinical trial data analysis, and statistical reporting to support drug development and regulatory submission activities.

The selected candidate will develop and validate Analysis Data Model (ADaM) datasets, Tables, Listings, and Figures (TFLs), and statistical analyses in accordance with Clinical Data Interchange Standards Consortium (CDISC) standards. Senior candidates will lead statistical programming activities, manage resources, mentor team members, and ensure the timely delivery of high-quality clinical study outputs.

## Key Responsibilities

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

- Develop and validate SAS programs for creating ADaM datasets in compliance with CDISC standards.

- Develop and oversee the preparation of Tables, Listings, and Figures (TFLs) for clinical studies.

- Program and validate statistical analyses using SAS and/or R.

- Ensure consistency and accuracy of ADaM datasets across individual studies and integrated analyses.

- Manage project deliverables, resource planning, effort estimation, and programming timelines.

- Ensure adherence to quality processes, project requirements, and applicable regulatory standards.

- Prepare regulatory submission documentation, including reviewer guides and data definition documents.

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

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

- Collaborate with statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing, and Clinical Operations teams.

- Support regulatory filings and ensure that programming deliverables meet submission requirements.

- Adapt to changing project priorities and ensure timely completion of deliverables.

## Required Skills and Qualifications

- Graduation is mandatory.

- Preferred educational backgrounds include Life Sciences, Computer Science, Statistics, or related disciplines.

- Minimum 2+ years of experience in SAS programming.

- Proficiency in SAS and/or R programming for clinical trial data analysis.

- Strong understanding of ADaM datasets, TFL development, and statistical programming.

- In-depth knowledge of CDISC standards and the clinical study lifecycle.

- Understanding of drug development processes and clinical trial reporting.

- Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience, or other relevant medical domains.

- Experience with regulatory submissions and associated documentation.

- Excellent written and verbal communication skills.

- Strong analytical, problem-solving, and organizational skills.

- Ability to work collaboratively with cross-functional teams and manage competing deadlines.

## Preferred Experience

- Experience leading statistical programming activities for a compound, indication, or therapeutic area.

- Experience managing and mentoring statistical programming teams.

- Hands-on experience with ADaM dataset development and TFL programming.

- Experience in integrated clinical study analyses and regulatory filings.

- Familiarity with additional statistical programming languages is an advantage.

## Salary and Work Details

- **Salary:** ₹9–20 LPA, depending on experience, technical expertise, and role level.

- **Locations:** Mumbai, Pune, Bangalore, or Noida.

- **Shift:** General shift.

- **Reporting Manager:** Delivery Manager.

## Important Hiring Conditions

- Former TCS employees are not eligible.

- Graduation is compulsory.

- PAN and Date of Birth (DOB) details are required for employee profile creation, subject to applicable data privacy and verification policies.

## Candidate Profile Match Score

**Profile matching percentage: To be assessed against the candidate's CV.**

Please share the candidate's resume to calculate a match percentage based on education, SAS/R programming experience, ADaM and TFL expertise, CDISC knowledge, regulatory filing experience, therapeutic area exposure, and team leadership responsibilities. A match score cannot be reliably assigned without reviewing the candidate's profile.