Job title : Clinical Data Services Senior Analyst

Job Description :

We are looking for a detail-oriented Clinical Data Services Senior Analyst to support Life Sciences R&D operations, including clinical trial data management, statistical programming, quality control, and clinical study deliverables. The role involves reviewing study protocols and specifications, validating clinical datasets and outputs, supporting safety and efficacy reporting, and ensuring compliance with applicable standards, SOPs, and quality guidelines.

Experience : 5–8 yrs

Location : Bengaluru, Karnataka

Required Skills : 

1. Clinical Data Services and Clinical Trial Support

2. SAS Programming and Standard Macros

3. Clinical Data Standards, including SDTM

4. Quality Control (QC) and Data Validation

5. Analytical, Problem-Solving, and Communication Skills

Key Responsibilities :

• Analyze moderately complex problems and develop solutions using established methods and procedures.

• Align deliverables with team objectives, project priorities, and management direction.

• Coordinate with study teams, offshore teams, onshore stakeholders, and clients to support smooth study execution.

• Collaborate with statistical programmers, study leads, and other project stakeholders.

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

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

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

• Perform developer testing and validate datasets and outputs against defined standards.

• Apply programming and data standards to improve consistency and operational efficiency.

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

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

• Mentor new hires, support onboarding, and resolve technical or process-related queries.

• Conduct Service Readiness Assessments and support resource management for ongoing and upcoming studies.

• Assist Statistical Programming Managers and Service Delivery Leads with operational reporting and daily activities.

• Complete assigned training on time and contribute to continuous improvement initiatives.

Qualifications : 

• Education: Any qualification, as specified in the role requirements.

• Relevant experience in Clinical Data Services, Clinical Research, or Statistical Programming.

• Strong analytical and problem-solving skills.

• Good written and verbal communication skills.

• Knowledge of SAS programming, clinical data standards, and clinical trial deliverables is relevant to the technical responsibilities.

• Ability to work independently on routine assignments and collaborate with multidisciplinary teams.

• Willingness to work in rotational shifts as required.

• Ability to mentor colleagues, maintain documentation, and follow quality and compliance standards.​

Important Points :

• Ex TCS Employees can't apply.

• PAN and DOB are required for profile creation.