Statistical Programmer

ACURA SOLUTIONS LTD; Mumbai; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

ACURA SOLUTIONS LTD in Mumbai, India, invites experienced Principal Statistical Programmer to lead SAS/R programming for regulated clinical trials. You will ensure CDISC SDTM/ADaM compliance, develop and validate analysis programs, and contribute to Define.xml and ADRG documentation.

The role requires mentoring junior programmers and coordinating cross-functionally to meet strict regulatory deadlines. The candidate should have a Statistics/CS degree, hands-on R in regulated settings, and strong

Qualifications

• Bachelor's or Master's in Statistics, Computer Science, or related field.
• At least 1 year of hands-on R programming in a regulated environment.
• Strong proficiency in SAS, CDISC SDTM/ADaM, and ADaM specification writing.
• Experience with P21 validation tools for regulatory readiness.
• Experience in safety/efficacy analysis programming in clinical trials.
• Strong project management, analytical and communication skills; ability to lead teams under deadlines.

Responsibilities

• Plan, coordinate, and execute programming, testing, and documentation of statistical programs to generate tables, figures, listing summaries (TFLs), and derived analysis datasets (Safety and/or Efficacy).
• Ensure full CDISC standards compliance (SDTM/ADaM); author/review ADaM specifications; utilize Pinnacle 21 for dataset validation and regulatory readiness.
• Create and maintain submission documentation, including ADRG and Define.xml.
• Leverage SAS and R programming for analyses, data manipulation, reporting, automation, and innovative programming solutions.
• Provide technical guidance on statistical methodologies, mentor junior programmers, and collaborate with cross-functional teams.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submission

Leadership & mentoring

Education

Bachelor's or Master's in Statistics/CS

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.