Job Title: Clinical Data Services Senior Analyst

Job Description

The Clinical Data Services Senior Analyst will be aligned with the Life Sciences R&D vertical, supporting clinical trial data management and medical monitoring activities. The role involves providing medical expertise for trial oversight and safety concerns, reviewing and validating protocol requirements, performing quality control checks, developing and validating SAS programs and clinical trial datasets, and ensuring compliance with applicable SOPs and quality standards.

The candidate will collaborate with study teams, statistical programmers, study leads, offshore teams, and onshore/client stakeholders to ensure smooth study execution. The role also involves mentoring new hires, supporting resource management and operational reporting, and contributing to technical and business excellence initiatives.

Key Responsibilities

• Analyze and resolve moderately complex clinical data and programming-related problems.

• Review approved protocols, study setup documents, submission documents, and output specifications.

• Perform QC checks for standard and non-standard safety and efficacy deliverables.

• Develop SAS programs and execute standard macros to generate SDTM-like and SDTM datasets, tables, listings, figures, and study-specific outputs.

• Perform developer testing and validate datasets and outputs according to defined standards.

• Apply programming and data standards to improve efficiency and consistency across studies.

• Maintain project, validation, and programming documentation as per SOP requirements.

• Interface with study teams, offshore teams, and onshore/client stakeholders.

• Collaborate with Senior Statistical Programmers, study leads, and programmers for effective study execution.

• Support service readiness assessments, resource management, operational reporting, and daily delivery activities.

• Mentor and guide new hires and support onboarding and technical/process queries.

• Ensure adherence to client and organizational SOPs and quality guidelines.

• Complete required training and continuously enhance technical skills.

• Support organizational, non-clinical, and business excellence initiatives.

Required Skills

• Clinical Data Services / Medical Monitoring

• Strong Analytical Skills

• Problem-Solving Skills

• SAS Programming & Clinical Data Standards

• Strong Written and Verbal Communication

• Clinical Trial Data Management

• Quality Control & Validation

• SDTM Dataset Development

Function / Role

Clinical Data Management / Statistical Programming

Process Type

Non-Voice

Important Eligibility

• 5–8 years of relevant experience in Clinical Data Services / Medical Monitoring.

• Strong knowledge of clinical trial data management and clinical data standards.

• Hands-on experience with SAS programming and development of clinical trial datasets and outputs.

• Knowledge of SDTM / SDTM-like datasets, tables, listings, and figures.

• Experience in QC, developer testing, validation, and SOP compliance.

• Strong analytical, problem-solving, written, and verbal communication skills.

• Willingness to work in rotational shifts.

• Ability to collaborate with study teams, statistical programmers, offshore teams, and client stakeholders.

• Education: Any.