Clinical Statistical Programmer

vueverse.; Thiruvananthapuram; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

vueverse. is seeking a Clinical Statistical Programmer to join our clinical analytics team in India. You will work onsite in multiple cities and collaborate with statisticians to implement SAPs and SPPs, and develop ADaM datasets and TLFs.

Requirements include a Master’s with 6+ years or a Bachelor’s with 8+ years in statistics or a related field, strong SAS and R skills, CDISC knowledge, and experience with cross-study analyses. Excellent communication and problem-solving are essential.

Qualifications

• Master's degree with 6+ years or Bachelor's degree with 8+ years in statistics, computer science, engineering, or related field.
• Proficiency in SAS and/or R for ADaM and SAP programming.
• Familiarity with CDISC standards and clinical study processes.

Responsibilities

• Collaborate with statisticians to develop SAPs and SPPs and create ADaM data specifications.
• Program and validate ADaM and statistical analyses using SAS/R.
• Generate TLFs for clinical study and safety reports with accuracy and regulatory compliance.
• Develop and maintain programming documentation and validation plans.
• Lead quality checks on deliverables and support cross-functional data analyses.
• Assist with audits, regulatory submissions, and study publications.

Skills

SAS

R

CDISC standards

ADaM

SAP

TLFs

Data analysis

Cross-study analysis

Communication skills

Problem solving

Education

Master's degree with 6+ years

Bachelor's degree with 8+ years

Tools

SAS

R (statistical software)

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.