About ClinPharmStats

PhD in Statistics with specialization in mixed models methodology for prediction of fixed and random effects, and in estimating variance components. Over 25 years of statistical experience including 13 years in the pharmaceutical and biotech companies and CROs.

Responsibilities in various assignments in the pharmaceutical industry included protocol development, writing Statistical Analysis Plans and programming specifications, supporting IDMC, DSMB and drug development advisory boards in evaluation and interpretation of clinical trial results and formulating recommendations, integrated summary of efficacy and safety, CRFs review, contributing to writing of clinical study reports and pre-NDA briefing packages, direct interactions with FDA reviewers and responding to FDA queries, assisting Regulatory Affairs in drafting letters of responses to FDA.

Therapeutic areas of experience include cardiovascular, hypertension, diabetes, oncology, Mesothelioma trials, Dermatology (Acne Vulgaris), CNS (Bipolar I Disorder and Schizophrenia), weight loss, anti-fungal, pain studies, diagnostic imaging, anti-infective (complicated skin structure infections, complicated intra-abdominal infection), postmenopausal management and contraceptive studies.

Shaun brings extensive expertise in data engineering, AI/ML implementation, biomedical AI systems, and statistical analysis to ClinPharmStats. With a strong foundation in biomedical data science, he excels at bridging the gap between clinical research, statistical methodology, and advanced technology solutions.

His work spans clinical data pipelines, medical imaging workflows, survival modeling, LLM-based tools, and statistical software development. He has applied methods including logistic regression, Cox proportional hazards models, Kaplan-Meier analysis, generalized additive models, decision curve analysis, C-index evaluation, AUC/F1 benchmarking, k-fold validation, stratified-split evaluation, and threshold optimization for clinical prediction and trial-matching workflows.

He has developed several open-source and research tools, including the widely used dcurves Python library for decision curve analysis, which has reached 60k+ downloads, along with biomedical AI platforms for dataset and model management, training and inference workflows, DICOM/NIfTI medical image review, clinical trial matching evaluation, and reproducible multimodal modeling pipelines.

Shaun is multilingual, speaking English, Mandarin Chinese, Hindi, Japanese, and Spanish, which enhances his ability to collaborate with international teams and clients. His unique combination of technical expertise, statistical training, and healthcare domain knowledge makes him an invaluable asset to ClinPharmStats and our clients.

Gaurav has over 15 years of experience in operations management within the pharmaceutical and healthcare industries. He specializes in optimizing project workflows, resource allocation, and process improvement.

At ClinPharmStats, Gaurav oversees day-to-day operations, ensures project timelines and deliverables are met, and coordinates between statistical teams and clients. His expertise in project management methodologies has been instrumental in streamlining our service delivery and enhancing client satisfaction.

Prior to joining ClinPharmStats, Gaurav held operations roles at leading CROs where he managed cross-functional teams and implemented process improvements that significantly reduced project timelines while maintaining quality standards.

His combination of business acumen and understanding of the clinical research landscape makes him an essential part of our leadership team, ensuring that our statistical expertise is delivered through efficient operational frameworks.