Aaseem Shaikh

About Aaseem Shaikh

I help transform complex clinical trial data into actionable, regulatory-ready insights that accelerate life-changing treatments. With 15+ years in pharma biostatistics and statistical programming, I bring deep expertise in CDISC SDTM & ADaM, SAS & R programming, TLFs and submission-ready datasets with a special focus on Neuroscience & Oncology.As a Senior Principal Statistical Programmer, I don’t just code - I drive data strategy, lead global programming teams and ensure every dataset or output meets the highest standards of quality, compliance and reproducibility. I bridge the gap between statistical rigor and real-world impact, supporting regulatory submissions, streamlining workflows and empowering cross-functional teams.I have successfully managed complex global projects at Novartis and Tata Consultancy Services, delivering critical milestones while maintaining regulatory compliance. My hands-on expertise includes advanced SAS programming, macro development, Pinnacle 21 for submission package generation and R programming for validation and automation.Known for collaborative leadership and mentoring, I drive process improvements, foster cross-functional team alignment and proactively contribute to company-wide initiatives. I am passionate about leveraging AI-driven tools and technology to boost programming efficiency, automate quality checks and deliver cleaner, faster results - helping sponsors and CROs accelerate life-saving treatments to patients.

Experience

1. Senior Principal Statistical Programmer

   Mars

   Apr 2025 — Present

   Develop and validate SDTM and ADaM datasets, ensuring CDISC compliance for clinical study submissions.Create R utility functions to automate and streamline SDTM and ADaM programming, improving dataset accuracy and efficiency.Generate Tables, Listings, and Figures (TFLs) using SAS and R, supporting statistical reporting and regulatory deliverables.Leverage AI-powered tools to enhance programming efficiency, automate repetitive tasks, and improve data quality.

Education

• Bharti Vidyapeeth College of Engineering - Mumbai University

  Bachelor of Engineering (B.E.) - Computer Science

  2008