Clinical Statistical Programmer

vueverse.; Faridabad District; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

vueverse. is seeking a Clinical Statistical Programmer to join our onsite team in multiple Indian locations (Hyderabad, Bengaluru, Pune, Chennai, Delhi NCR).

The role requires a Master’s degree with 6+ years (or a Bachelor's with 8+ years) in statistics, CS, engineering or related field, and strong SAS/R skills to program ADaM, SAPs, and TLFs. The incumbent will prepare ADaM specifications, generate TLFs, maintain documentation, and support audits/submissions.

Qualifications

• 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.
• Proficiency in SAS / R programming languages to program and validate ADaM, TLF and statistical analyses.
• Understanding of statistical methods, data analysis techniques, and clinical research processes.
• Advance knowledge of CDISC standards and therapeutic areas (Oncology, Immunology, Neuroscience, etc.).
• In-depth understanding of the drug development process and clinical study lifecycle.
• Familiarity with clinical study protocols, SAPs, TLFs, and programming documentation.

Responsibilities

• Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP) and implement SAPs to create ADaM data specifications.
• Program and validate ADaM and statistical analyses using SAS/R, ensuring adherence to standards.
• Generate tables, listings, and figures (TLFs) for clinical study reports and safety reports.
• Develop and maintain programming documentation and validation plans.
• Perform quality control checks on statistical programming deliverables.
• Collaborate with cross-functional teams for ad hoc data analyses and data visualizations.
• Lead development of standard programming macros and utilities to improve efficiency.
• Stay updated with industry best practices and regulatory guidelines.
• Lead audits, inspections, and regulatory submissions related to statistical programming.
• Provide programming support to statisticians and study teams and assist in publications.
• Meet customer requirements within agreed timelines and quality standards.
• Coach/Mentor new team members as needed.

Skills

SAS

R

ADaM

TLFs

CDISC

SAPs

Statistical Methods

Cross-study Analyses

Teamwork

Communication

Education

Master's or Bachelor's in Statistics/CS/Engineering

Tools

SAS Studio

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.