Statistical Programmer

ACURA SOLUTIONS LTD; Gurugram District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

ACURA SOLUTIONS LTD seeks Principal Statistical Programmer to lead programming across clinical trials with a focus on accuracy, integrity, and regulatory compliance. You will develop, validate, and maintain complex analysis programs, ensuring SDTM/ADaM compliance and data readiness for submissions.

You will mentor junior programmers, collaborate with cross-functional teams, and drive process improvements using SAS and R, with Pinnacle 21 for dataset validation and regulatory readiness.

Qualifications

• Bachelors or Masters in Statistics, CS, or a related field.
• Hands-on SAS programming in a regulated environment.
• Strong CDISC SDTM/ADaM knowledge and ADaM specification writing.
• Pinnacle 21 validation experience.
• Experience in Safety and/or Efficacy analysis programming in clinical trials.
• Proven leadership, project management, and communication skills.

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.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

ADaM specification writing

Pinnacle 21 validation

Leadership / mentoring

Education

Bachelor's or Master's in Statistics/Computer Science

Tools

Pinnacle 21

Job description

Principal 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.