I am a certified Clinical SAS Programmer with a pharmacy background, specializing in oncology Phase III trials. My expertise includes building and validating ADaM datasets, generating safety/efficacy outputs, and applying CDISC standards.
My pharmacy degree enhances my understanding of clinical concepts, adverse events, and study designs, fostering strong collaboration with biostatistics and clinical teams. I focus on producing clean, traceable code for regulatory submissions.
Key Technical Skills
SAS Expertise
Base, Advanced, Macros, SQL, ODS for robust data manipulation and reporting.
CDISC Standards
Proficient in SDTM and ADaM mapping for compliant data structures.
TLF Generation
Developing Demographics, AE Summaries, Disposition, and Kaplan-Meier Survival outputs.
Oncology Analyses
Specialized in Overall Survival (OS), Progression-Free Survival (PFS), and CTCAE Grading.
ADaM Domains & Oncology Focus
ADSL
Subject-level analysis dataset.
ADTTE
Analysis dataset for time-to-event.
ADAE
Analysis dataset for adverse events.
ADVS
Analysis dataset for vital signs.
Oncology
OS, PFS, CTCAE Grading.
Tools & Compliance
Software Tools
SAS 9.4
Medidata Rave
Microsoft Office
Windows 10/11
Regulatory Compliance
ICH-GCP
21 CFR Part 11
Data Validation
QC, SAP Interpretation
Soft Skills for Success
Analytical Mindset
Problem-solving and critical thinking.
Attention to Detail
Ensuring accuracy in all outputs.
Documentation Discipline
Clear and thorough record-keeping.
Team Collaboration
Effective teamwork and communication.
Clinical SAS Programmer Experience
1
Signetsoft
Aug 2024 – Jan 2025 | Bengaluru, India
Oncology | Phase III | Randomized Double-Blind Trial | mCRPC
Developed CDISC-compliant ADaM datasets (ADSL, ADTTE, ADAE, ADVS).
Derived key endpoints, including OS variables.
Programmed and validated over 10 safety and efficacy outputs.
Created Table 1 and time-to-event outputs using PROC REPORT and PROC LIFETEST.
Ensured programming traceability, documentation, and validation accuracy.
Pharmacist Experience
Aster DM Healthcare
Feb 2024 – Jun 2024 | Bengaluru, India
Verified prescriptions and dispensed medications accurately.
Maintained compliant documentation and inventory.
Gained strong detail orientation and clinical knowledge.