Clinical Statistical Programmer

vueverse.; Mangaluru; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

vueverse. is seeking a Clinical Statistical Programmer to join our onsite team across India locations including Hyderabad, Bengaluru, Pune, Chennai and Delhi NCR.

The role requires a Master’s degree with 6+ years or a Bachelor's with 8+ years in statistics or related fields, with strong SAS/R skills and CDISC experience. You will develop SAP/SPP, create ADaM data specifications, generate TLFs, and ensure regulatory submission quality.

Qualifications

• Master's or Bachelor's with substantial experience in statistics, computer science, engineering, or related field.
• Proficient in SAS and/or R for ADaM, TFLs and SAPs; strong data analysis capabilities.
• Deep understanding of CDISC standards and drug development processes.
• Experience with cross-study analyses and regulatory submission readiness.
• Attention to detail, problem solving, and clear communication with teams.

Responsibilities

• Collaborate with statisticians to develop, review, and approve SAP/SPP and ADaM data specs.
• Program and validate analyses using SAS/R, ensuring standards compliance.
• Generate TLFs for study reports and safety documentation with accuracy.
• Maintain programming documentation and validation plans.
• Perform quality checks on deliverables to ensure regulatory readiness.
• Support data analyses, visualization, and exploratory analyses as needed.
• Lead development of standard macros and tools to improve efficiency.
• Stay updated on industry guidelines and regulatory requirements.
• Support audits/inspections and regulatory submissions as required.
• Provide programming support for publications and data queries.
• Complete tasks per customer requirements within timelines and quality expectations.
• Escalate issues, provide status updates, and highlight risks.
• Coach/mentor new team members when needed.

Skills

SAS programming

R programming

TLF generation

CDISC standards

SAP/SSP

Data validation

Statistical analysis

Cross-functional teamwork

Communication skills

Audit readiness

Education

Master's degree

Bachelor's degree

Job description

Role: Clinical Statistical Programmer

Location : Hyderabad, Bengaluru, Pune, Chennai, Delhi NCR

Mode of work : Onsite (5 days a week)

Educational Qualification / Experience for the role:

Master's degree with 6+ years of experience or bachelor's degree with 8+ years of experience in statistics, computer science, engineering, or a related field

Required Skillsets:

• Proficiency in SAS / R programming languages to Program and validate ADaM, TFL and statistical analyses
• Proficiency in using statistical software and programming tools
• Understanding of statistical methods, data analysis techniques, and clinical research processes.
• Advance knowledge of CDISC standards and therapeutic area (Oncology, Immunology, Neuroscience etc.)
• In-depth understating of drug development process and clinical study life cycle
• Familiarity clinical study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation.
• Strong experience in generating TLFs, programming macros, and data manipulation using SAS.
• Good to have experience in other statistical programming languages (R).
• Experience working on cross-study, integrated data analysis.
• Strong attention to detail and quality Focus
• Problem-solving skills (Ability to identify and troubleshoot programming issues)
• Effective communication skills (both written and verbal)
• Ability to interact professionally with statisticians, study teams, and external partners
• Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.

Key Responsibilities:

• Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and SPP to create ADaM data specifications.
• Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines.
• Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements.
• Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans.
• Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards.
• Collaborate with cross-functional teams to support ad hoc data analyses, data visualization, and exploratory analyses as needed.
• Ability to lead the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks.
• Stay updated with industry best practices, regulatory guidelines, and emerging technologies in statistical programming and data analysis.
• Lead the planning and execution of statistical programming-related audits, inspections, and regulatory submissions, ensuring compliance with relevant regulations and guidelines.
• Collaborate with statisticians and study teams to provide programming support, address data-related queries, and contribute to study-related publications.
• Performs assigned task(s) in accordance with customer requirements within agreed timelines and Quality.
• Escalates unresolved issues appropriately to Team Lead /Project Lead. Tracks and follows up on all issues raised. Provides timely status updates. Proactively highlight risk.
• Coach/Mentor/Train new team members and line function as per requirement.