Senior Clinical Data Scientist
Department: Research & Development (R&D) – Clinical Data Science
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Experience Required: 3–5 Years
Industry: Pharmaceutical / Biotechnology / Clinical Research / Data Science
Position Overview
We are seeking a highly analytical and technically proficient Senior Clinical Data Scientist to support global clinical development programs through advanced statistical programming, clinical data analysis, and operational trial support.
The successful candidate will serve as a key operational partner within clinical trial teams, ensuring the delivery of high-quality clinical data science solutions across the trial lifecycle. This role combines expertise in clinical data standards, statistical programming, regulatory compliance, and cross-functional collaboration to generate reliable clinical evidence that supports regulatory submissions and strategic decision-making.
The ideal candidate will have strong programming expertise in SAS and/or R, a solid understanding of clinical development processes, and experience supporting statistical analysis and reporting for clinical trials.
Key Responsibilities
Clinical Trial Data Science Leadership
Lead Clinical Data Science activities for assigned clinical studies and development programs.
Act as the primary Clinical Data Science representative within trial squads and cross-functional project teams.
Plan, coordinate, and execute clinical data science deliverables throughout the clinical trial lifecycle.
Provide scientific and operational expertise to support study execution and decision-making.
Clinical Data Standards & Study Setup
Lead study setup activities including:
Electronic Case Report Form (eCRF) Design
Data Flow Plan Development
Blinding Plan Development
Data Standards Implementation
Ensure consistency with organizational and regulatory requirements throughout study setup and execution.
Support implementation of clinical data standards and best practices across studies.
Statistical Programming & Analysis
Perform and oversee statistical programming activities using SAS and/or R.
Ensure high-quality generation and validation of:
SDTM Datasets
ADaM Datasets
Tables, Listings, and Figures (TLFs)
Analysis Outputs
Conduct data transformations, statistical analyses, and reporting activities according to protocol requirements and industry standards.
Support preparation of clinical study reports and regulatory submission packages.
Regulatory Submission Support
Ensure submission-ready clinical datasets and analysis outputs comply with regulatory requirements.
Support preparation and review of regulatory documents including:
Risk Management Plans (RMPs)
Investigator Brochures (IBs)
Development Safety Update Reports (DSURs)
Clinical Study Reports (CSRs)
Regulatory Submission Packages
Maintain compliance with CDISC standards and applicable regulatory guidelines.
Trial Execution & Operational Support
Review and provide input into:
Clinical Study Protocols
Statistical Analysis Plans (SAPs)
Data Management Plans
Clinical Reporting Documents
Support interpretation and communication of clinical trial results.
Monitor study progress and ensure timely completion of data science deliverables.
Maintain inspection readiness throughout study execution.
Vendor & CRO Management
Collaborate with Contract Research Organizations (CROs) and external vendors.
Review vendor deliverables to ensure compliance with quality standards and project requirements.
Support oversight of outsourced programming and data science activities.
Ensure effective communication and alignment between internal and external stakeholders.
Knowledge Sharing & Innovation
Facilitate learning sessions and knowledge-sharing initiatives across teams.
Mentor junior team members and contribute to capability development.
Drive process improvements and identify opportunities for innovation.
Promote automation, efficiency, and advanced analytical methodologies.
Present best practices, lessons learned, and innovative solutions at departmental and global forums.
Required Qualifications
Education
Bachelor’s or Master’s Degree in:
Life Sciences
Statistics
Biostatistics
Computer Science
Data Science
Engineering
Mathematics
Natural Sciences
or other relevant disciplines.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Japan | Saitama |Tokyo :
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