Job Description

Position Summary

The Biostatistician will play a key role in the design, analysis, and interpretation of Real World Data (RWD) and Real-World Evidence (RWE) studies supporting pharmaceutical and healthcare research initiatives. This role involves applying advanced statistical methodologies to large, complex datasets from claims, EMRs, registries, and observational studies to generate insights that inform clinical, regulatory, and commercial strategies.

Key Responsibilities

Design statistical analysis plans and implement methodologies for RWD and RWE studies aligned with study objectives and regulatory expectations. Conduct statistical analyses using large-scale healthcare databases (claims, EMR/EHR, registries, and linked data sources). Develop and validate statistical models for comparative effectiveness, treatment pattern, and safety outcomes. Collaborate cross-functionally with epidemiologists, data scientists, medical affairs, and HEOR teams to define project requirements and data strategies. Ensure high-quality documentation and reproducibility of analyses in accordance with industry and regulatory standards (e.g., FDA, EMA, ISPE). Contribute to publication development, conference abstracts, and internal scientific presentations. Provide statistical support for RWE protocol designs, feasibility assessments, and data curation. Mentor junior statisticians or analysts in RWE methodologies and best practices.

Qualifications

Master's or PhD in Biostatistics, Statistics, Epidemiology, or a related quantitative field. 5-7 years of experience in pharmaceutical or healthcare research, with at least 3+ years in RWD/RWE study design and analysis. Strong programming proficiency in SAS and/or R; experience with SQL or Python preferred. Hands-on experience working with real-world datasets such as claims, EHRs, or registries. In-depth understanding of observational study designs and causal inference methods (e.g., propensity scores, IPTW, instrumental variables). Working knowledge of regulatory guidance pertaining to RWE submissions and data standards. Excellent communication skills, with the ability to interpret and present complex findings to scientific and non-technical stakeholders.
Job Type: Full-time

Pay: ₹1,500,000.00 - ₹2,500,000.00 per year

Work Location: Remote