Senior Statistical Programmer
Location: Hyderabad, India (Hybrid)
Job ID: R1451479
Employment Type: Full Time
About the Role:
IQVIA is seeking an experienced Senior Statistical Programmer to lead and support end-to-end statistical programming activities for global clinical trials. This role combines technical excellence, leadership, and client interaction while working in a hybrid model from Hyderabad.
You will be responsible for delivering high-quality statistical outputs, managing timelines, supporting regulatory submissions, and mentoring junior programmers—all while contributing to innovative medical research that improves global patient outcomes.
Key Responsibilities:
Statistical Programming & Quality Control:
Create and review complex programs for datasets (SDTM/ADaM), tables, listings, and figures (TLFs).
Ensure code accuracy and validation as per SOPs and regulatory standards.
Monitor programming logs, maintain data integrity, and resolve inconsistencies.
Study Lead Functions:
Serve as statistical programming lead on clinical studies, working closely with cross-functional teams.
Coordinate project timelines, resource planning, and client communications.
Conduct internal meetings, provide timely updates, and ensure budget alignment.
Data Management & Analysis Plans:
Review case report forms (CRFs), and collaborate on database designs and validation checks.
Contribute to Statistical Analysis Plans (SAPs) and mock shells for outputs.
Develop specifications for analysis datasets and TLFs.
Documentation & Reporting:
Write or review statistical sections in protocols, clinical study reports (CSRs), and SAPs.
Support database lock and unblinding processes.
Handle documentation for audits, regulatory submissions, and internal quality checks.
Mentorship & Training:
Mentor and train junior programmers.
Share knowledge across teams and promote statistical best practices.
Lead by example and support cross-functional collaboration.
Client Engagement:
Occasionally act as the primary client contact for statistical programming matters.
Participate in proposal reviews, bid defenses, and RFP responses.
Risk & Financial Management:
Identify risks to delivery timelines and suggest mitigation plans.
Ensure work is within scope and supports budget control and revenue recognition.
Requirements:
Bachelor’s in Biostatistics or related field with 7+ years of experience OR
Master’s with 6+ years OR Ph.D. with 5+ years in relevant programming roles.
Advanced expertise in SAS and working knowledge of other statistical tools (e.g., nQuery).
Strong understanding of CDISC/ADaM standards and regulatory guidelines (GCP, ICH).
Effective communication, analytical thinking, and leadership skills.
Ability to lead small teams, manage multiple projects, and resolve programming challenges independently.
What We Offer:
A collaborative, innovation-driven environment in a global organization.
Opportunities for career advancement, skill development, and global project exposure.
Flexibility through hybrid working arrangements.
The satisfaction of working on projects that make a real difference in patient care.
Estimated Salary: ₹18–28 LPA (based on industry standards in Hyderabad for senior statistical programming roles)
About IQVIA:
IQVIA is a global leader in clinical research, real-world evidence, and advanced healthcare analytics. We connect data, technology, and expertise to accelerate life sciences innovation and improve outcomes for patients worldwide. Learn more at jobs.iqvia.com
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