Clinical Statistical Programmer

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

Job summary

vueverse. Clinical Statistical Programmer role onsite in India. Requires 6+ years with a Master’s (or 8+ years with a Bachelor’s) in statistics, CS, or engineering, and strong SAS/R/CDISC experience. You will develop SAPs, ADaM data specifications, and TLFs, collaborating with statisticians and study teams.

The role involves generating TLFs, maintaining documentation, quality control, audits, regulatory submissions, and cross-study analyses in an onsite setting.

Qualifications

• Master's degree with 6+ years or bachelor's with 8+ years in statistics, computer science, engineering, or related field.
• Strong proficiency in SAS/R and CDISC standards.
• Experience with ADaM, SAPs, TLFs and clinical study lifecycle.

Responsibilities

• Collaborate with statisticians to develop and review SPP and implement SAPs and SPP to create ADaM data specifications.
• Program and validate ADaM datasets and analyses using SAS/R, ensuring adherence to standards.
• Generate TLFs for clinical study reports, safety reports and other deliverables with accuracy.
• Develop and maintain programming documentation, specifications, and validation plans.
• Perform quality control checks on statistical programming deliverables.
• Collaborate with cross-functional teams for ad hoc analyses and data visualization.
• Lead development of standard programming macros and tools for efficiency.
• Stay updated with regulatory guidelines and industry best practices.
• Lead audits/inspections and regulatory submissions support.
• Provide programming support to study teams and publications.
• Escalate issues, track status, and mentor new team members.

Skills

SAS

R

ADaM

TLFs

SAP

CDISC

Data analysis

Cross-functional collaboration

Problem-solving

Communication

Education

Master's degree in statistics/computer science/engineering

Bachelor's degree in statistics/computer science/engineering

Tools

SAS

R

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.