Rahul Vaidya
SDTM and SAS Programming Maestro | Quality Review | Clinical Data Transformation | Clinical Research | Data Transformation | Elevating Pharma Data Standards & Compliance
- Role
- Team Lead, Statistical Programming at Diagnosearch Life Sciences
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Rahul Vaidya
With nearly two decades in statistical programming and clinical data management…
Experience
Team Lead, Statistical Programming
Aug 2024 — Present · 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.
Education
Savitribai Phule Pune University
B. Sc., Statistics
1995 — 2000
Indsearch Pune
MCM, Computer Management
2000 — 2002
Academy of Clinical Excellence
Bio statistics and Data Management
Skills
- Clinical Study Design
- Clinical Trials
- Statistical Programming
- Sdtm
- Validation
- Data Management
- Clinical Data Management
- Statistics
- Sas Programming
- Vba
- Cdisc
- Sas
- Clinical Research
- Biostatistics
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