Ashish Parkhe
Pune
Summary
Dynamic Lead Clinical Data Science Programmer with expertise at Icon Strategic Solutions, specializing in risk-based monitoring and data integration. Proven track record in enhancing data quality through advanced statistical analysis and effective team leadership. Adept at leveraging SAS programming and fostering collaboration to drive impactful clinical research outcomes.
Overview
3
3
Languages
8
8
years of professional experience
Work History
Lead Clinical Data Science Programmer (Central Monitoring) FSP
Icon Statergic Solution
09.2026 - Current
- Leading the design, development, and validation of data science programming solutions to support clinical trials, including data integration, statistical analysis, and reporting.
- Managing and mentoring a team of clinical data programmers, providing guidance and ensuring adherence to programming standards and best practices.
- Overseeing data quality assurance processes, including data validation and verification, to ensure the accuracy and completeness of clinical trial data.
- Completed study setups in Cluepoints per study-specific central monitoring plan, ensuring comprehensive review of KRI, QTL, DQA, duplicate subjects, and audit trails.
- Collaborated with clinical research teams and stakeholders to define data requirements, develop programming specifications, and implement effective data science methodologies.
- Utilized advanced statistical techniques and data visualization tools to analyze complex data sets, generating actionable insights that informed clinical research decisions.
- Staying current with industry trends and advancements in data science and clinical research and recommending innovative solutions to enhance data analysis and reporting.
Data Surveillance Analyst, Risk based Monitoring.
Parexel International
Bengaluru
02.2024 - 09.2025
- Provides leadership and expertise in all aspects of Data Surveillance and the set-up of support technologies, managing the delivery of all relevant data surveillance activities.
- Support the development of a robust Data Surveillance Plan, Key Risk Indicators, Quality Tolerance Limits and Data Surveillance technologies.
- Review relevant data via the Data Surveillance application, Clue Points, DDM Application and Document findings.
- Identify and evaluate data quality issues and identify potential solutions aligned with Parexel's business and technology strategy.
- Recognized and communicated impact of study non-compliance, delays, and data quality signals, promptly escalating site and study issues to FL for immediate action.
- Conducted presentations on data surveillance processes and technologies to enhance understanding of findings and analytical methods.
- Participated in cross-functional meetings to align initiatives and report on metrics.
Central Monitor, Risk Based Monitoring, DMM
Pfizer Healthcare India Pvt Ltd.
Mumbai
11.2021 - 02.2024
- General:
- Provide technical expertise to set up and test study level Risk-based Monitoring system
- Ensure RBM system aligns with the protocol and adheres to ICH GCP, SOPs, corporate standards and regulatory requirements.
- Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level.
- Reviewed study level system outputs to identify signal and action management improvements for implementation during study.
- Work with Clinical Data Scientist to ensure all signal and actions are properly mitigated and RBM systems properly released.
- Established system functions to streamline monitoring processes.
- Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
- Set up dictionary for data quality assessment DQA in study system
- Provided technical oversight and coordinated central monitor activities to ensure alignment with project objectives.
Statistical Analyst/Programmer, Data Monitoring
Tata Constancy Services Limited
Thane
07.2018 - 11.2021
- Monitor the quality of reporting and analyze SDTM data on multiple studies.
- Identify the systemic issues using risk based monitoring techniques using SAS JMP software.
- Graphical representation of critical data using SAS and R.
- Generated SM reports and collaborated with study teams to address issues and implement solutions.
- Applied standard QTLs on studies and monitored progress throughout study lifecycle.
- Managed daily responsibilities across multiple tasks to ensure project continuity.
Education
Master of Science - Statistics
Modern College of Arts, Commerce And Science
Shivajinagar, Pune06-2018
Bachelor of Science - Statistics
S.P. College
Pune05-2016
Skills
- CluePoints configuration
- Risk based monitoring
- Data integration
- Statistical analysis
- Data quality assessment
- Data integrity monitoring
- SAS programming
- Data visualization
- Clinical data review
Personal Information
Runner, Biker and father
Languages
English
Intermediate (B1)
B1
Marathi
Advanced (C1)
C1
Hindi
Upper Intermediate (B2)
B2
Timeline
Lead Clinical Data Science Programmer (Central Monitoring) FSP
Icon Statergic Solution
09.2026 - Current
Data Surveillance Analyst, Risk based Monitoring.
Parexel International
02.2024 - 09.2025
Central Monitor, Risk Based Monitoring, DMM
Pfizer Healthcare India Pvt Ltd.
11.2021 - 02.2024
Statistical Analyst/Programmer, Data Monitoring
Tata Constancy Services Limited
07.2018 - 11.2021
Master of Science - Statistics
Modern College of Arts, Commerce And Science
Bachelor of Science - Statistics
S.P. College