Statistical Programmer

ACURA SOLUTIONS LTD; Chennai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

ACURA SOLUTIONS LTD seeks a Principle Statistical Programmer (Sr./Principal) to lead statistical programming across clinical trials in India. Develop, validate, and maintain complex analysis programs while ensuring regulatory compliance and data integrity.

You will drive CDISC SDTM/ADaM workflows, author ADaM specifications, and utilize SAS, R, and Pinnacle 21 tooling to deliver submission-ready datasets, tables, and listings.

Qualifications

• Education: Bachelors or Masters in Statistics, CS, or related field.
• Hands-on R programming in regulated environments (1+ year).
• Strong SAS programming and CDISC SDTM/ADaM experience.
• Experience with efficacy/safety analysis in clinical trials.
• Ability to lead projects and meet regulatory deadlines.

Responsibilities

• Plan, coordinate, and execute programming, testing, and documentation of statistical programs for TFLs and derived datasets.
• Ensure CDISC SDTM/ADaM compliance and use P21 for validation and regulatory readiness.
• Create and maintain submission docs including ADRG and Define.xml.
• Develop SAS/R solutions for analyses, data manipulation, and automation.
• Provide technical leadership and mentor junior programmers; collaborate with cross-functional teams.

Skills

Regulatory mindset

Leadership

Communication

Education

Bachelor's or Master's in Statistics, CS or related field

Tools

SAS programming

R programming

Pinnacle 21 (P21) validation tools

CDISC SDTM/ADaM standards

Job description

Job Overview

Principle Statistical Programmer (Grades G150 G160)

PAN INDIA

We are seeking skilled Statistical Programmers (Sr. and Principal levels) to ensure the accuracy, integrity, and regulatory compliance of statistical programming across various clinical trial projects. You will develop, validate, and maintain complex analysis programs, provide advanced technical leadership, and drive process improvements within the statistical department.

Key Responsibilities

• Programming Deliverables: Plan, coordinate, and execute the programming, testing, and documentation of statistical programs to generate tables, figures, listing summaries (TFLs), and derived analysis datasets (Safety and/or Efficacy).
• CDISC Standards Validation: Ensure full compliance with CDISC standards (SDTM and ADaM), author/review ADaM specifications, and utilize Pinnacle 21 (P21) for dataset validation and regulatory readiness.
• Regulatory Documentation: Create and maintain submission documentation, including Analysis Data Reviewers Guides (ADRG) and Define.xml.
• Process Tool Development: Leverage SAS and R programming for statistical analyses, data manipulation, reporting, automation, and the implementation of innovative programming solutions.
• Leadership Collaboration: Provide technical guidance on statistical methodologies, mentor junior programmers, collaborate with cross-functional teams, and serve as a statistical team lead for complex studies.

Mandatory Requirements Qualifications

• Education: Bachelors or Masters degree in Statistics, Computer Science, or a related field.
• R Programming: Minimum 1 year of hands-on R programming experience in a regulated environment.
• Technical Expertise: Strong proficiency in SAS programming, CDISC SDTM/ADaM standards, ADaM specification writing, and P21 validation tools.
• Analysis Experience: Proven background in Safety and/or Efficacy analysis programming within clinical trials, including the creation of efficacy datasets and outputs.
• Core Competencies: Strong project management, analytical, problem-solving, and communication skills with the ability to lead teams and meet strict regulatory deadlines.