Job Overview

We are looking for a Clinical Data Services Senior Analyst to support the Life Sciences R&D vertical. The role will contribute to clinical trial data management, programming, validation, quality control, and study execution while ensuring compliance with applicable SOPs and quality standards.

The position involves working across study teams, offshore teams, and onshore/client stakeholders to support clinical research activities and deliver high-quality clinical trial outputs.

Key Responsibilities

• Analyze and solve moderately complex clinical data and programming problems by adapting existing methods and procedures.

• Work in alignment with team objectives and strategic direction defined by senior management.

• Independently handle routine assignments while seeking guidance for new or complex activities.

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

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

• Perform Quality Control (QC) checks for standard and non-standard safety and efficacy deliverables.

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

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

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

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

• Maintain project, validation, and programming documentation in accordance with SOP requirements.

• Follow client and organizational SOPs, quality guidelines, and applicable standards.

• Mentor and guide new hires, assist with onboarding, and resolve technical or process-related queries.

• Conduct and assess Service Readiness Assessments for new resources.

• Support resource management activities for ongoing and upcoming studies.

• Assist Statistical Programming Managers and Service Delivery Leads with operational reporting and day-to-day support.

• Complete assigned training within required timelines and continuously enhance technical capabilities.

• Participate in organizational, non-clinical, business excellence initiatives, and task forces.

• Work in rotational shifts as required.

Qualifications & Skills

• 5–8 years of relevant experience.

• Education: Any.

• Strong analytical and problem-solving skills.

• Strong written and verbal communication skills.

• Experience or knowledge in Clinical Data Services – Medical Monitoring.

• Experience working with clinical trial data and related study documentation.

• Knowledge of SAS programming and clinical trial datasets.

• Understanding of SDTM and clinical trial data standards.

• Experience with data validation, developer testing, and QC activities.

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

• Strong attention to detail and commitment to quality and SOP compliance.

• Ability to mentor and guide junior/new resources.

• Willingness to work in rotational shifts.