Chaitali Onkar Raut
Pune
Summary
Results-driven Sr. Statistical Programmer with extensive experience at Syneos Health, specializing in ADaM and TLF creation. Proficient in Base SAS and SAS MACROS, I excel in delivering high-quality data insights while fostering collaboration within cross-functional teams. Committed to enhancing clinical trial outcomes through innovative programming solutions.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Sr. Statistical Programmer
Syneos Health Private Limited
Pune
01.2021 - Current
- Expertise in SAS Programming: Proficient in BASE SAS, SAS Macros, and SAS-SQL, with strong hands-on experience in developing and validating ADaM datasets and TLFs (Tables, Listings, and Figures) in compliance with CDISC standards.
- Clinical Domain Knowledge: Solid understanding of clinical trial domains, particularly in Safety and Efficacy data analysis, with experience supporting regulatory submissions and ensuring data integrity.
- Leadership & Project Management: Successfully led multiple studies by maintaining detailed trackers, managing resources, and ensuring alignment with project milestones and deliverables.
- Cross-Functional Collaboration: Worked closely with Biostatisticians, Statistical Programmers, Clinical Data Managers, and Project Managers to deliver high-quality outputs on time and within scope.
- Validation & Documentation Support: Served as a validation programmer, coordinating study activities and contributing to key project documentation such as Statistical Analysis Plans (SAPs), TFL Shells, and ADaM specifications.
Statistical Programmer
TATA Consultancy Services
Noida
11.2018 - 12.2020
- SDTM Development: Experienced in creating and validating SDTM datasets in compliance with CDISC standards, ensuring accurate data transformation and submission readiness.
- SAS Programming Proficiency: Skilled in BASE SAS, SAS Macros, and SAS-SQL for clinical data manipulation, cleaning, and reporting.
- CRF Annotation: Proficient in annotating Case Report Forms (CRFs) to link eCRF fields with SDTM variables, supporting traceability and regulatory compliance.
- Domain Knowledge: Strong understanding of clinical trials processes, with a focus on safety and efficacy data domains, ensuring high-quality data outputs for regulatory and internal reporting.
Clinical SAS Programmer Intern
ClipLab-Cytel
08.2018 - 10.2018
Education
MSc - Statistics
Savitribai Phule Pune University
01.2017
BSc - Statistics
Savitribai Phule Pune University
01.2015
HSC -
Maharashtra State Board
01.2012
SSC -
Maharashtra State Board
01.2010
Skills
- ADaM
- TLF
- Base SAS
- SAS MACROS
- SAS-SQL
- Clinical trial domains
- SDTM
- CRF annotation
- Table and listing creation
- Base SAS programming
- R Studio
- Minitab
- Matlab
- Microsoft Office
Professional Summary
Clinical SAS programmer with 6.8 years of experience in ADaM, TFLs, and SDTM mapping Proficient in BASE SAS, SAS Macros, and statistical procedures for clinical data analysis and reporting. Skilled in creating ADaM from SDTM, SDTM from raw data, and generating safety listings and tables Strong background in data cleaning, dataset validation (PROC COMPARE), and advanced SAS procedures.
Certification
- SAS Certified Base Programmer for SAS 9
- Certificate in Statistical Analysis with using R programming
Disclaimer
I hereby declare that all the details furnished above are true to the best of my Knowledge and belief.
Timeline
Sr. Statistical Programmer
Syneos Health Private Limited
01.2021 - Current
Statistical Programmer
TATA Consultancy Services
11.2018 - 12.2020
Clinical SAS Programmer Intern
ClipLab-Cytel
08.2018 - 10.2018
MSc - Statistics
Savitribai Phule Pune University
BSc - Statistics
Savitribai Phule Pune University
HSC -
Maharashtra State Board
SSC -
Maharashtra State Board
Similar Profiles
Srishti ShettySrishti Shetty
Central Monitor I at Syneos Health India Private LimitedCentral Monitor I at Syneos Health India Private Limited
Purnima BhargawPurnima Bhargaw
Safety and PV Specialist II at Inventiv International Pharma Services Private Limited (Syneos Health)Safety and PV Specialist II at Inventiv International Pharma Services Private Limited (Syneos Health)
SANDEEP KUMARSANDEEP KUMAR
safety and pharmacovigilance specialist 2 at Syneos health limitedsafety and pharmacovigilance specialist 2 at Syneos health limited
Ankit KulhadeAnkit Kulhade
Sr. Software Developer at Accenture Solution Pvt LtdSr. Software Developer at Accenture Solution Pvt Ltd
Akhila K PAkhila K P
Product Owner at FINASTRAProduct Owner at FINASTRA