Lead Statistical Programmer
Location: Bangalore, Karnataka (Hybrid)
Department: Service Delivery
Employment Type: Full Time | Experienced
Company Overview:
Sitero is a leading clinical research and healthcare solutions provider, committed to transforming patient outcomes through cutting-edge technologies and services. We are looking for a detail-oriented and proactive Lead Statistical Programmer to join our growing team and play a crucial role in ensuring high-quality statistical programming for clinical trials.
Position Summary:
As a Lead Statistical Programmer, you will provide clinical and statistical programming expertise in generating SDTM and ADaM datasets, tables, listings, and figures (TLFs) from clinical trial data. You will be responsible for overseeing the accuracy, integrity, and compliance of programming deliverables with regulatory and internal standards while mentoring junior programmers and supporting cross-functional project teams.
Primary Responsibilities:
Data Programming & QC:
Develop and execute SAS programs for edit checks, data conversions, and TLF outputs.
Create CDISC-compliant datasets (SDTM/ADaM) based on clinical protocols and sponsor requirements.
Prepare and validate statistical datasets and outputs with thorough documentation and testing.
Perform quality assurance reviews on programming work done by peers.
Documentation & Process:
Prepare User Requirement Specifications (URS), CDM conventions, and SAS validation documentation.
Maintain and develop SAS macro libraries and format libraries.
Contribute to the development of standard operating procedures (SOPs) and process improvements.
Cross-functional Collaboration:
Coordinate with CDM, QA, and Project Managers to ensure timely and accurate deliverables.
Review and approve technical documents, and assist in study-level planning and resource forecasting.
Technical Oversight & Maintenance:
Provide support for SAS environment installation, updates, and system maintenance.
Participate in testing protocol-specific programs and ensure seamless integration of tools.
Secondary Responsibilities:
Identify and implement opportunities to improve departmental efficiency.
Assist with training programs for new clinical programmers.
Maintain current technical knowledge through ongoing training and industry engagement.
Qualifications:
Education:
Bachelor's degree in Computer Science, Biostatistics, or a related field.
Educational background in informatics, cognitive science, or applied sciences is an advantage.
Experience:
8+ years of SAS programming experience in a pharma/CRO setting – Required.
5+ years working with CDISC standards (SDTM/ADaM), SQL, and relational databases – Required.
3+ years of experience with clinical database structures, data extraction, and listing/report generation – Required.
Skills:
Excellent attention to detail and commitment to data integrity.
Strong communication (written and verbal) and documentation skills.
Ability to work independently as well as in cross-functional teams.
Strong project management and time management abilities.
Adaptability to changing priorities and fast-paced environments.
Working Conditions:
Travel: 5–20%
Physical Requirements: Lifting (0–25 lbs), prolonged computer use.
Estimated Salary: ₹18–25 LPA
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