Rahul Vaidya

Team Lead, Statistical Programming @Diagnosearch Life Sciences

Thane, IN

As a lead statistical programming professional, I focus on ensuring quality and compliance throughout the project lifecycle. Key contributions include:Regulatory Compliance: Maintain up-to-date knowledge of company SOPs and relevant regulations (CDISC, 21 CFR), providing training to team members on essential protocols.Quality Assurance: Supervise and review programming outputs to ensure quality control for derived datasets, tables, listings, and figures, ensuring readiness for audits.Statistical Analysis: Collaborate in the interpretation of Statistical Analysis Plans (SAP) and transform specifications into documented, tested programs for Clinical Trial Reports.Program Development: Develop and standardize SAS programs, maintaining a library to enhance efficiency and streamline processes.Documentation & Submission: Prepare comprehensive source (SDTM) and analysis (ADaM) submission packages with meticulous documentation for electronic regulatory submissions.Training & Development: Mentor programmers on SDTM and ADaM guidelines, promoting continuous learning and development within the team.Project Management: Ensure all project documentation is updated and archived, reflecting a commitment to organizational integrity and operational excellence.I strive to embody the company\'s core values in all interactions, fostering strong relationships with both internal and external stakeholders while continuously enhancing my skills to meet evolving project needs.

Savitribai Phule Pune University

B. Sc., Statistics

Indsearch Pune

MCM, Computer Management

Academy of Clinical Excellence

Bio statistics and Data Management