Statistical Programmer

ACURA SOLUTIONS LTD; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

ACURA SOLUTIONS LTD is seeking a Principal Statistical Programmer to lead statistical programming across diverse clinical trials. You will develop, validate, and maintain complex analysis programs, ensuring regulatory compliance and data integrity. Experience in Safety/Efficacy analyses and CDISC standards is essential.

The role requires strong leadership, project management, and collaboration with cross-functional teams to deliver high-quality outputs on tight regulatory deadlines.

Qualifications

• Bachelor's or Master's degree in Statistics, Computer Science, or related field.
• Hands-on SAS programming in regulated environments.
• Experience with CDISC SDTM/ADaM standards and ADaM specifications writing.
• Experience performing Safety/Efficacy analysis programming for clinical trials.
• Ability to lead teams, manage projects, and meet regulatory deadlines.

Responsibilities

• Plan, coordinate, and execute programming, testing, and documentation of statistical programs for tables, listings, figures, and derived datasets.
• Ensure CDISC SDTM/ADaM compliance and use Pinnacle 21 for validation and regulatory readiness.
• Create and maintain submission documents, such as ADRG and Define.xml.
• Leverage SAS and R for analyses, data manipulation, reporting, automation, and innovative programming.
• Provide technical guidance, mentor junior programmers, and lead statistical projects.

Skills

SAS programming

CDISC SDTM/ADaM

ADaM specification writing

Pinnacle 21 validation

R programming

Leadership & mentoring

Regulatory deadlines

Education

Bachelor's or Master's in Statistics/CS

Tools

Pinnacle 21

Define.xml tooling

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.