Nipun Shah

Results-driven SAS Consultant with over 4 years of experience in the clinical research domain, providingexpert SAS programming and biostatistical analysis support. Proven ability to develop and validate SASprograms for complex clinical trials across therapeutic areas including Respiratory, Oncology, Cardiology,and Haematology. Expertise in CDISC standards (SDTM, ADaM), statistical reporting, and generating TLFs for regulatory submissions.

Willing to relocate: Anywhere

Core Biostatistical and SAS Programming Skills:

• Clinical Trial Analysis: Proficient in developing and implementing Statistical Analysis Plans (SAPs), performing complex statistical analyses (survival, longitudinal, mixed-effects), and generating TLFs for CSRs, regulatory submissions, and publications.
• SAS Expertise: Skilled in SAS/STAT, SAS/BASE, SAS/GRAPH, and SAS macros for data manipulation, analysis, and reporting.
• CDISC Standards: Experienced in developing and validating SAS programs for data extraction, transformation, and analysis, ensuring compliance with SDTM and ADaM standards.
• Medical Coding: Proficient in applying medical coding dictionaries (MedDRA, WHODrug) for adverse event analysis.
• Consultation: Provides biostatistical consultation to clinical teams, contributing to study design and protocol development.

Project Leadership and Management:

• Project Management: Leads and manages biostatistics and SAS programming projects, ensuring timely delivery within budget.
• Team Leadership: Supervises and mentors junior biostatisticians and SAS programmers, providing technical guidance and support.
• Cross-Functional Collaboration: Coordinates with data management, clinical operations, and medical writing teams.
• Risk Management: Identifies and mitigates project risks and issues.
• Best Practices: Develops and implements best practices for biostatistical analysis and SAS programming.

Python and R Integration:

• Data Analysis and Visualization: Utilizes Python and R for exploratory data analysis, data visualization, and specialized statistical modeling.
• Integration: Integrates Python and R with SAS to enhance data processing and analytical capabilities.
• Scripting: Develops and maintains scripts and functions in Python and R.

Regulatory Compliance and Documentation:

• Regulatory Expertise: Ensures compliance with FDA and EMA guidelines and CDISC standards.
• Regulatory Submissions: Prepares and reviews regulatory submission documents.
• Documentation: Creates and maintains comprehensive documentation of statistical analyses, SAS programs, and data specifications.
• SOPs and Training: Contributes to the development of SOPs and training materials.

Bachelor of Pharmacy from Rajiv Gandhi University of health Science

Graduate Certificate in Strategic Global Business Management from Conestoga College.