Ananya K U
Bengaluru
Summary
Pharmaceutics graduate with SAS Certified Specialist: Base Programming Using SAS 9.4 credential. Strong foundation in pharmaceutical sciences, clinical data management, and SAS statistical programming. Hands-on experience in generating SDTM/ADaM datasets and TLFs. Skilled in regulatory compliance, data integrity, and cross-functional collaboration. Seeking an entry-level opportunity in clinical research or statistical programming to apply SAS expertise and drive data-driven decisions in healthcare.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Statistical Programming Intern
Novartis Pharmaceuticals
09.2022 - 03.2023
- Gained hands-on experience in SAS Base programming for clinical data analysis using CDISC standards
- Learned to create SDTM and ADaM datasets, and to develop Tables, Listings, and Figures (TLFs) for domains such as DM, AE, VS, and PC
- Understood the process of drafting programming specifications and the importance of maintaining audit trails
- Applied SAS programming to a real-time pharmacokinetic dataset as part of an academic project, simulating regulatory deliverables
- Handled raw clinical trial data from approximately 20 patients, and successfully created SDTM and ADaM datasets for key domains including DM (Demographics), AE (Adverse Events), and VS (Vital Signs)
- Strengthened conceptual understanding of data lifecycle, regulatory frameworks, and industry-standard programming practices in clinical trials
Formulation, QA, QC Intern
Medreich India
06.2021 - 07.2021
- Completed training in formulation, quality assurance, and control processes, covering over 10+ key unit operations in solid and liquid dosage forms
- Observed and understood the pharmaceutical manufacturing workflow during a 4-week hands-on industrial training program, including batch documentation, in-process checks, and compliance procedures
Education
Master of Pharmacy - Pharmaceutics
Manipal College of Pharmaceutical Sciences
Manipal07-2023
Bachelor of Pharmacy - Pharmaceutical Sciences
PES College of Pharmacy
Bengaluru10-2021
Skills
- Clinical & Regulatory Knowledge
ICH-GCP certified; knowledge of clinical trial phases & regulatory deliverables
Familiar with CDISC standards (SDTM, ADAM) and domains (DM, AE, VS, PC)
Exposure to PK data, SOPs, audit trails, and compliance workflows
- SAS Programming & Data Analytics
SAS Certified Specialist: Base Programming Using SAS 94
Experienced with PROC MEANS, FREQ, TRANSPOSE, SQL, and reporting procedures
TLF generation using SDTM/ADAM datasets;
Pharmaceutical Manufacturing & QA Training
Trained in formulation, QA/QC processes, and GMP documentation
Familiar with solid/liquid dosage operations and in-process checks
- Soft Skills
Detail-oriented, compliance-focused, and organized
Strong analytical and communication skills
Adaptive team player with a continuous learning mindset
Certification
- Certified SAS Certified Specialist: Base
Programming Using SAS 9.4, SAS Global Certification Program - June 2025
Timeline
Statistical Programming Intern
Novartis Pharmaceuticals
09.2022 - 03.2023
Formulation, QA, QC Intern
Medreich India
06.2021 - 07.2021
Master of Pharmacy - Pharmaceutics
Manipal College of Pharmaceutical Sciences
Bachelor of Pharmacy - Pharmaceutical Sciences
PES College of Pharmacy
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