ARNAB SARKAR

• Developing and implementing novel methodologies to enable efficient safety signal detection using blinded data and other external data sources
• Developing safety analytics framework focusing on aggregated review
• Leading safety signal detection analytics in development projects targeting multiple indications

Leading quantitative strategy in early development of multiple molecules focusing on immunology and chronic pain indications, in collaboration with cross-functional project teams

• Driving scientific excellence through application of innovative adaptive designs and other lean strategies in early phase development
• Successfully developed and implemented holistic decision framework for compound prioritization with Bayesian methodology
• Managing statistical teams for high-priority project deliverables

Working as Bayesian methodology consultant for safety signal detection in a global pharmaceutical company (Client), focusing on -

• Bayesian meta-analytic methods for aggregated analysis of adverse events to enable blinded safety signal detection.

• Improved signal detection using Bayesian hierarchical partially exchangeable modeling (NEXEX) for all relevant AEs grouped by MedDRA hierarchy

• Bayesian estimation of required follow-up for safety monitoring of rare side effects for detecting signal.

• High-quality visualization of safety events

Designing early phase studies in respiratory disease area and biosimilar development studies in oncology

Leading design and analysis activities in confirmatory clinical trials in Cardiovascular& Metabolic Therapeutic area

• Performed complex simulation-based analysis for justifying primary endpoint selection to FDA for a study in acute myocardial infarction

• Responded to health-authority questions with high-quality innovative analyses with quick turnaround time

Performing planned and exploratory statistical analyses to support decision making for Phase II/ III clinical trials in Cardiovascular & Metabolic disease area