Senior Statistical Programmer
Location: Hyderabad, India (Hybrid)
Job ID: R1451479
Job Type: Full Time
About the Role:
IQVIA is hiring an experienced Senior Statistical Programmer to contribute to the planning, execution, and oversight of statistical programming activities for global clinical studies. The role involves leading study-level programming, preparing high-quality deliverables, ensuring compliance with regulatory requirements, and mentoring junior team members. This position is ideal for professionals with strong SAS programming expertise and experience in clinical trials.
Key Responsibilities:
Programming & Validation:
Develop statistical methods sections for protocols and review case report forms (CRFs).
Write and maintain programming specifications for datasets, tables, listings, and figures (TLFs).
Validate code and ensure clean processing of clinical data according to SOPs.
Perform quality control checks on programming outputs and resolve data issues.
Leadership & Study Management:
Act as statistical programming lead on individual studies.
Manage timelines, coordinate with project team leads, and ensure deliverables are on time and within budget.
Run internal meetings, document decisions, and follow up on project actions.
Contribute to project-level budget tracking and EAC (Estimate at Completion) reporting.
Data Analysis & Documentation:
Author or QC Statistical Analysis Plans (SAPs) and shells.
Support database lock and unblinding processes under supervision.
Assist with protocol development, sample size calculation, and statistical report writing.
Participate in CSR (Clinical Study Report) development and proposal review.
Client Interaction & Cross-Functional Collaboration:
Communicate with clients on statistical and operational topics.
Provide guidance to internal and external teams on best statistical practices.
Occasionally serve as the primary point of contact for customers.
Engage in bid defenses and proposal development for new studies.
Mentorship & Knowledge Sharing:
Provide training and mentorship to new and junior programmers.
Promote efficient statistical programming practices and team collaboration.
Share statistical knowledge across projects and support continuous process improvement.
Risk & Financial Oversight:
Identify risks to delivery and propose mitigation strategies proactively.
Monitor scope changes and ensure budget adherence.
Share accountability for the financial success of assigned studies.
Qualifications:
Bachelor's in Biostatistics or related field with 7+ years of relevant experience
OR Master's with 6+ years
OR Ph.D. with 5+ years
Strong proficiency in SAS and statistical computing (e.g., nQuery).
Deep understanding of CDISC/ADaM and clinical data standards.
Strong grasp of ICH-GCP and regulatory guidelines.
Excellent communication, leadership, and problem-solving skills.
Ability to work on multiple studies and lead small project teams effectively.
Estimated Salary: ₹18–28 LPA (based on industry standards for Hyderabad location)
About IQVIA:
IQVIA is a global leader in clinical research and data-driven healthcare solutions, providing advanced analytics, technology, and consulting to support life sciences innovation. Join us and be part of a team that transforms patient outcomes worldwide.
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