Job Description: Clinical Data Services Senior Analyst

Job Title: Clinical Data Services Senior Analyst

Job Location: Bengaluru, India

Experience: 5–8 Years

Job Code: AIOC-S01639556

Primary Skill: Clinical Data Services – Medical Monitoring

Education: Any Graduate

Job Summary

We are looking for an experienced Clinical Data Services Senior Analyst to join our Life Sciences R&D team in Bengaluru. The role focuses on clinical trial data management, medical monitoring support, statistical programming, safety and efficacy deliverables, and quality control.

The candidate will collaborate with clinical study teams, statistical programmers, study leads, and onshore/offshore stakeholders to ensure accurate, consistent, and high-quality clinical trial data and outputs in compliance with applicable Standard Operating Procedures (SOPs), client requirements, and industry standards.

Roles and Responsibilities

Analyze clinical trial requirements and develop solutions using established methods, procedures, and programming standards.

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

Support medical monitoring activities, trial oversight, and safety-related requirements.

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

Perform quality control (QC) checks for standard and non-standard safety and efficacy deliverables.

Conduct developer testing and validate datasets, statistical outputs, and clinical trial deliverables against approved specifications.

Ensure compliance with applicable SOPs, client guidelines, validation requirements, and clinical data standards.

Maintain accurate programming, validation, and project documentation in accordance with quality requirements.

Collaborate with Senior Statistical Programmers, study leads, programming teams, and other stakeholders to ensure smooth study execution.

Act as a key point of contact between study teams, offshore teams, and onshore/client stakeholders.

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

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

Conduct Service Readiness Assessments for new resources and evaluate their readiness for project assignments.

Support resource planning and management for ongoing and upcoming clinical studies.

Assist Statistical Programming Managers and Service Delivery Leads with operational reporting and day-to-day project activities.

Complete mandatory training within defined timelines and continuously enhance technical and domain knowledge.

Participate in organizational initiatives, business excellence programs, and continuous improvement activities.

Be flexible to work in rotational shifts as required.

Required Skills and Competencies

Strong analytical, problem-solving, and decision-making skills.

Good understanding of clinical trial data, safety and efficacy reporting, and medical monitoring requirements.

Hands-on experience with SAS programming and clinical trial datasets.

Knowledge of SDTM standards, clinical study documentation, and statistical programming deliverables.

Experience in quality control, developer testing, output validation, and documentation.

Understanding of SOPs, quality guidelines, and clinical research compliance requirements.

Strong written and verbal communication skills.

Ability to work independently, manage multiple priorities, and collaborate effectively with cross-functional teams.

Stakeholder management skills, with the ability to coordinate with onshore and offshore teams.

Mentoring, knowledge-sharing, and team collaboration capabilities.

Preferred Qualifications

5–8 years of relevant experience in clinical data services, clinical research, medical monitoring support, or statistical programming.

Experience in pharmaceutical, biotechnology, or clinical research environments.

Familiarity with clinical trial safety and efficacy outputs, submission deliverables, and regulated documentation practices.

Experience supporting project delivery, resource readiness assessments, and operational reporting.

Key Expectations

The successful candidate will contribute to the delivery of high-quality clinical trial data and programming outputs, maintain compliance with established quality standards, support cross-functional study execution, and help improve operational efficiency across the Life Sciences R&D organization