Biostatistics Senior Associate – Data Visualization
Location: Hyderabad, India
Work Type: On-Site
Department: Clinical Development
Position Summary
The Biostatistics Senior Associate – Data Visualization is responsible for providing statistical expertise and analytical support across clinical studies throughout the drug development lifecycle. This role involves applying biostatistical methodologies, developing statistical programming solutions, creating interactive visualizations, and supporting regulatory deliverables to ensure scientifically sound and high-quality study outcomes.
The position collaborates closely with cross-functional teams including Biostatistics, Statistical Programming, Clinical Development, Data Management, and Regulatory Affairs to deliver timely, compliant, and decision-ready analyses.
Key Responsibilities
Statistical Analysis & Interpretation
Apply appropriate biostatistical methods to analyze and interpret clinical trial data.
Support clinical studies across various phases of drug development.
Contribute to statistical strategy discussions and analytical decision-making.
Ensure statistical analyses meet scientific and regulatory requirements.
Statistical Programming & Data Visualization
Develop and maintain statistical programming solutions using:
R
Python
Design and implement data visualization and reporting solutions.
Develop interactive dashboards and analytical tools using R Shiny and related technologies.
Create automated reporting and data visualization workflows.
Support reproducible research and reporting practices.
Clinical Trial Support
Collaborate with study teams to ensure timely delivery of statistical outputs.
Support clinical trial design, analysis, and reporting activities.
Contribute to study-level statistical deliverables and documentation.
Participate in data review and interpretation activities.
Regulatory & Submission Support
Support preparation of regulatory submission deliverables.
Ensure compliance with industry standards, including:
CDISC SDTM
CDISC ADaM
Assist in the preparation and review of statistical documentation.
Support regulatory inspections and audit readiness activities.
Documentation & Quality Compliance
Assist in reviewing and maintaining:
Standard Operating Procedures (SOPs)
Statistical Guidelines
Controlled Documents
Internal Policies
Ensure all statistical activities comply with regulatory requirements and internal quality standards.
Maintain documentation accuracy, traceability, and compliance.
Automation & Process Improvement
Build automated workflows and reporting pipelines to improve efficiency and consistency.
Identify opportunities to enhance statistical programming and reporting processes.
Evaluate and implement innovative technologies that improve productivity and quality.
Support adoption of AI and automation tools where appropriate.
Cross-Functional Collaboration
Work closely with:
Biostatisticians
Statistical Programmers
Clinical Development Teams
Data Management Teams
Regulatory Affairs Teams
Contribute to project planning, timelines, and deliverables.
Provide statistical expertise during study discussions and reviews.
Basic Qualifications
Candidates must meet one of the following requirements:
Master's Degree
Master's Degree in Statistics, Biostatistics, or a related field with substantial statistical coursework.
Minimum 4 years of post-graduate experience as a Statistician in:
Pharmaceutical Industry
Biotechnology Industry
Medical Research
Doctoral Degree
Doctoral Degree (PhD) in Statistics, Biostatistics, or a related field with substantial statistical coursework.
Minimum 2 years of post-graduate experience as a Statistician in a relevant industry or research setting.
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