Location: Bangalore, Karnataka (Hybrid)
Department: Service Delivery
Employment Type: Full-time | Experienced
Sitero is a leading provider of clinical research and healthcare solutions, committed to advancing medical research and improving patient outcomes through innovative technologies and expert services. As we continue to grow, we are seeking a highly skilled and detail-oriented Lead Statistical Programmer to join our team.
The Lead Statistical Programmer will lead the development, validation, and delivery of SDTM and ADaM datasets, as well as listings, tables, and figures (TLFs) for clinical trial reporting. The role includes SAS programming, quality review, CDISC-compliance, and mentoring junior team members while ensuring adherence to regulatory and company standards.
Programming & Data Management
Develop and execute SAS edit check programs for clinical data validation.
Create SAS programs to transform EDC data into protocol-specific datasets per sponsor specifications.
Build and maintain SAS macros, format libraries, and project-specific documentation.
Validate programs following standard validation practices.
CDISC & Regulatory Compliance
Create and maintain CDISC-compliant datasets and associated documentation.
Review and approve User Requirement Specifications (URS), CDM conventions, and SOPs.
Support the development and enhancement of Clinical Data Management (CDM) systems.
Quality Assurance
Perform peer review of programming deliverables for accuracy and compliance.
Support Study Quality Representatives in protocol-specific SAS conversion program testing.
Project Management
Define, track, and meet project timelines; communicate changes to stakeholders.
Collaborate with Clinical Programming, Operations Programming, QA, Project Management, and Data Management teams to optimize workflows.
Training & Process Improvement
Mentor and train new programmers in coding standards and CDISC requirements.
Identify opportunities for efficiency gains in programming and data handling processes.
Contribute to team initiatives and process improvement projects.
Maintain up-to-date technical knowledge via training and industry developments.
Ensure compliance with company Standard Operating Procedures (SOPs) and quality standards.
Education
Bachelor’s degree in Computer Science, Statistics, or related field (required).
Additional background in human-computer interaction, usability, or information design is a plus.
Experience
8+ years SAS programming in pharmaceutical/clinical research industry (required).
5+ years experience with CDISC, SQL, and relational databases (required).
3+ years working with database structures for report generation (required).
Skills
Strong programming, data analysis, and validation skills.
Excellent attention to detail and documentation practices.
Strong communication and collaboration abilities.
Ability to manage multiple projects with changing priorities.
Travel: 5–20%
Lifting: Up to 25 lbs
Environment: Extended computer work
Slug: lead-statistical-programmer-sitero-bangalore
Estimated Salary Range: ₹25 – ₹35 LPA (based on experience)
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