Chandana Sri K
Hyderabad
Summary
Experienced Clinical SAS Programmer with 4+ years in pharmaceutical and CRO settings. Specializes in CDISC SDTM/ADaM programming, TLF generation, and regulatory submissions (FDA/PMDA). Proficient in Base SAS, Macros, and Pinnacle 21 Enterprise, focusing on quality, efficiency, and compliance. Skilled in cross-functional collaboration with biostatistics, data management, and regulatory teams.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Statistical Programmer-II
Quanticate
07.2023 - Current
- Led SDTM and ADaM dataset programming in compliance with CDISC standards.
- Developed reusable SAS Macros, improving deliverable efficiency by 25%.
- Performed Pinnacle 21 validations ensuring regulatory compliance (FDA readiness).
- Collaborated with global biostatistics and regulatory teams on submission projects.
Executive Statistical Programmer
CBCC Global Research
02.2023 - 06.2023
- Created SDTM/ADaM datasets per SDTMIG 3.2 standards.
- Designed and generated TLFs as per mock shells for clinical reports.
- Automated recurring outputs using SAS Macros, enhancing process efficiency by 25%.
- Partnered with clinical data management and regulatory departments.
Statistical Programmer
Croissance Clinical Research
08.2021 - 01.2023
- Developed and validated SDTM datasets (DM, AE, DS, CM, EX, VS, LB, EG).
- Prepared mapping specifications and CRFs in alignment with CDISC standards.
- Authored and executed QC documentation for audit readiness.
- Conducted data review and raised clinical queries for resolution with cross-functional teams.
Clinical SAS Programmer Intern
Stansys Software Solutions
12.2020 - 05.2021
- Gained hands-on experience in SDTM/ADaM mapping and TLF generation.
- Trained in regulatory-compliant SAS programming workflows.
- Developed and validated datasets to ensure compliance with clinical trial standards.
Education
Doctor of Pharmacy (Pharm-D) - Medical
KVSR Siddhartha College of Pharmaceutical Sciences, Krishna University
09.2020
Skills
- Programming: SAS (Base, Macro, SQL, Graph), SQL
- Standards: CDISC SDTMIG 32, ADaM, CDASH
- Tools: Pinnacle 21 Enterprise, SAS ODS (RTF, PDF, HTML)
- Databases: Oracle, MS Access
- OS: Windows, UNIX
- Office: MS Word, Excel, PowerPoint
Certification
- SAS Certified Specialist: Base Programming Using SAS 9.4
- Good Clinical Practice (GCP), NIDA Clinical Trials Network
- Jan 2024
- Diploma in Health & Nutrition
Languages
English
Telugu
Publications
- Prophylactic antibiotics by International Journal of Current Pharmaceutical Research
- Jul 2021
- Demonstrated effectiveness of Cephalosporins/Nitro-imidazoles in reducing post-op complications
Timeline
Statistical Programmer-II
Quanticate
07.2023 - Current
Executive Statistical Programmer
CBCC Global Research
02.2023 - 06.2023
Statistical Programmer
Croissance Clinical Research
08.2021 - 01.2023
Clinical SAS Programmer Intern
Stansys Software Solutions
12.2020 - 05.2021
Doctor of Pharmacy (Pharm-D) - Medical
KVSR Siddhartha College of Pharmaceutical Sciences, Krishna University
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