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Lead Statistical Programmer

8+ years
₹25 – ₹35 LPA
10 Aug. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Lead Statistical Programmer

Location: Bangalore, Karnataka (Hybrid)
Department: Service Delivery
Employment Type: Full-time | Experienced


Company Overview

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.


Position Overview

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.


Primary Responsibilities

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.


Secondary Responsibilities

  • 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.


Qualifications

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.


Working Conditions

  • 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)