SK
SHLOK KADBE
E: [email protected] | +91-7828742512 | A: Thane, IN 400601 |
LinkedIn: https://www.linkedin.com/in/shlokkadbe/
PROFESSIONAL SUMMARY TECHNICAL SKILLS
Certified SAS Programmer with over 3 years of experience in the • Programming Languages: Base
pharmaceutical and life sciences industry, specializing in clinical SAS, SAS Macros, PROC SQL
data management, statistical programming, and • Reporting Tools: SAS ODS, PROC
pharmacovigilance. Proficient in developing, validating, and REPORT, PROC GPLOT
maintaining SAS programs for data transformation, ETL processes, • EDC Platforms: Medidata Rave,
and report generation. Experienced in working with clinical EDC Oracle Inform, Argus Safety
systems such as Medidata Rave and Argus Safety, with strong • Clinical Standards: CDISC (SDTM,
understanding of CDISC standards (SDTM, ADaM), GCP, and ADaM), MedDRA, WHO-DD
regulatory compliance (21 CFR Part 11). • Databases & Integration: SQL, MS
Excel, ETL Processes
Excels in designing and troubleshooting clinical data systems, • Regulatory Knowledge: GCP,
collaborating across cross-functional teams, and continuously FDA 21 CFR Part 11, Audit-
improving technical processes. Seeking to leverage strong EDC Readiness
programming knowledge in a Clinical Data Programmer or EDC • Data Management: Edit Check
Developer role. Programming, Data Cleaning,
UAT Support
• Visualization & Analysis: Power BI
(Certified), Statistical Data
PROFESSIONAL EXPERIENCE
Summarization
Tata Consultancy Services - SAS Data Analyst
Mumbai
09/2023 - Current CORE COMPETENCIES
• Designed and maintained clinical EDC datasets aligned with
SAS Programming: Skilled in Base
protocol requirements.
SAS, Macros, PROC SQL, ODS for
• Developed robust SAS programs for data extraction,
clinical data analysis and reporting.
transformation, and loading (ETL).
• Ensured data integrity and regulatory compliance with GCP and EDC Systems: Working knowledge of
CDISC standards. Medidata Rave, Inform, and Argus
• Collaborated with statisticians and clinical data managers to Safety for study build and data
support UAT and study builds. entry.
• Generated validated TLFs using PROC REPORT, PROC GPLOT, and Edit Check Programming:
SAS MACROs. Experience in writing and validating
edit checks, derivations, and
Tata Consultancy Services - Pharmacovigilance Associate
custom functions.
Mumbai
08/2021 - 09/2023 CDISC Standards: Familiar with SDTM
and ADaM for clinical trial data
• Performed structured data entry and case processing in Argus
standardization.
Safety.
• Handled coding using MedDRA and WHO-DD dictionaries across Clinical Data Management:
spontaneous and literature cases. Proficient in data cleaning,
• Managed serious/non-serious case classification and discrepancy management, and
coordinated license partner submissions. database lock support.
• Supported unblinding and safetrack operations; awarded for ETL Processes: Experience in data
operational excellence. extraction, transformation, and
loading for statistical outputs.
System Troubleshooting: Capable of
resolving issues in SAS programs and
EDC platforms.
EDUCATION
Compliance: Understanding of GCP,
Kalinga University FDA 21 CFR Part 11, and clinical
06/2021 documentation standards.
Bachelor of Pharmacy Medical Coding: Hands-on
experience with MedDRA and
WHO-DD coding.
Collaboration: Strong
communication, problem-solving,
and cross-functional teamwork skills.
