Clinical Statistical Programmer

vueverse.; Malappuram; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

vueverse. Clinical is seeking a Clinical Statistical Programmer to join our onsite team across Hyderabad, Bengaluru, Pune, Chennai, or Delhi NCR. You will design and implement ADaM datasets, generate TLFs, and ensure regulatory-compliant analyses in collaboration with statisticians.

The ideal candidate has 6+ years of SAS/R programming experience, strong CDISC knowledge, and excellent communication. You will mentor junior programmers, help maintain programming standards, and support audits and

Qualifications

• Master's degree with 6+ years of experience in statistics or related field.
• Strong experience in SAS/R programming for ADaM and SAP/TLF generation.
• In-depth knowledge of CDISC standards and clinical trial processes.

Responsibilities

• Collaborate with statisticians to develop and approve SAPs and SPPs.
• Program and validate ADaM datasets and statistical analyses.
• Generate TLFs for study reports and regulatory submissions.
• Maintain programming documentation and validation plans.
• Perform QC checks for accuracy and consistency of outputs.
• Support cross-functional data analyses and data visualization.
• Lead development of programming macros and utility tools.
• Stay updated on regulatory guidelines and industry best practices.
• Assist with audits, inspections, and study publications.

Skills

SAS

R

ADaM

TLFs

CDISC standards

Statistical analysis

Problem solving

Communication

Teamwork

Mentoring

Education

Master's degree in statistics or related field

Bachelor's in statistics/CS/engineering

Tools

SAS

R

TLFs

ADaM

SAS Macro

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.