Pranaikya Vallagachu

Public Health professional with a Master of Public Health (MPH) in Health Education & Promotion and over 5 years of experience in healthcare analytics, clinical research, clinical data management, and SAS programming. Experienced in supporting Phase I–IV clinical trials, developing and validating CDISC-compliant SDTM and ADaM datasets, generating Tables, Listings, and Figures (TLFs), and contributing to regulatory submission packages in compliance with FDA, ICH-GCP, HIPAA, and 21 CFR Part 11 guidelines. Strong expertise in SAS programming (Base SAS, Macro, SQL, ODS, STAT) with proven ability to analyze complex healthcare and clinical data, perform data validation, ensure data integrity, and support evidence-based decision-making.

Skilled in epidemiological research, biostatistics, public health data analysis, healthcare analytics, program evaluation, and population health assessment. Hands-on experience with clinical data platforms including Medidata Rave, REDCap, Oracle Clinical, and EDC systems, supporting CRF review, edit checks, query resolution, data cleaning, and audit readiness activities. Adept at collaborating with cross-functional teams including biostatistics, clinical operations, regulatory affairs, safety, and data management to deliver high-quality study outputs and public health initiatives.

Detail-oriented and results-driven professional recognized for managing multiple projects simultaneously, maintaining regulatory compliance, improving data quality, and translating complex healthcare data into actionable insights that support clinical research and public health outcomes.

Clinical Trial Data Management & SaaS Coordination Platform at Him & Hers (2024-09 – Present)

• Coordinated clinical trial activities using SaaS platforms like Medidata Rave and REDCap for data capture and validation
• Managed CRFs (Case Report Forms), ensuring accuracy, completeness, and compliance with protocol requirements
• Performed data cleaning, query resolution, and discrepancy management in coordination with clinical data managers and biostatisticians
• Supported SDTM and ADaM dataset review aligned with FDA submission standards
• Conducted edit checks validation and ensured data integrity across multiple clinical sites
• Coordinated with cross-functional teams including clinical operations, safety, and regulatory teams
• Assisted in clinical trial monitoring activities, including site communication and documentation tracking
• Generated reports and dashboards using tools like SAS and Excel for trial progress and data insights
• Ensured compliance with HIPAA, GCP (Good Clinical Practice), and company SOPs
• Supported audit readiness and regulatory inspections, maintaining documentation for submissions

CLINICAL SAS PROGRAMMER at Medpace (2020-08 – 2023-07)

• Participated in the SAS programming for multiple clinical trials and ISS/ISE. Successfully handled lead programmer responsibilities including gathering requirements, creating specifications, developing codes, validating and documenting programs.
• Created/validated CDISC SDTM and ADaM compliant datasets along with its metadata specifications. Reviewed and provided comments for statistical analysis plans and specifications for the mock shells.
• Combined data from multiple studies to create pooled datasets for reporting of ISS/ISE.
• Created standard Safety tables for Adverse Events, Concomitant Medications, Electrocardiograms, Vital Signs, and Labs.
• Generated shift tables, change from baseline tables, and outputs for Efficacy Endpoints.
• Created SAS macros for reporting of the multiple tables across studies and for the similar tables for subgroup analyses.
• Coordinated work on multiple studies simultaneously as per priorities and met all study timelines.
• Produced annotated Survival Curves.
• Provided programming support for Ad-hoc analysis and reports.

CLINICAL SAS PROGRAMMER at Presto Dental (2019-10 – 2020-07)

• Contributed in study-related activities such as review of CRF, and SDTM and ADaM specification document.
• Reviewed edits check specifications to ensure data accuracy and data validity/integrity
• Created, analyzed and summarized safety and efficacy SDTM and ADaM dataset associated with clinical studies, as per the specifications in the SAP (statistical analysis plans) at study-level and project-level.
• Performed statistical analysis of efficacy endpoints using various SAS procedures such as Univariate, Freq, Glm, Mixed, Logistic, and Lifetest.
• Generated TLGs using ADaM datasets, programming specification documents, SAP and TLG shells.
• Create customized figures for clinical study reports as well as ad-hoc requests using SAS procedures Gplot and Gchart.
• Generated CRT packages and validated them for FDA submission.
• Modified/validated existing SAS macros to report summary as well as descriptive statistics.
• Performed validation of SAS programs and standard macros using company guidelines and communicated findings to the programmer/ biostatistician

DENTALSIBAR Institute of Dental Sciences (2019-01 – 2019-09)

• Delivered preventive oral healthcare services, including patient education, oral hygiene instruction, and tobacco cessation counselling aligned with public health guidelines.
• Performed chairside assistance and basic clinical procedures such as scaling, polishing, fluoride application, and preliminary oral examinations under supervision.
• Utilized Dental Practice Management Software (DPMS) / Electronic Health Records (EHR) systems for patient scheduling, clinical documentation, treatment planning, and billing workflows.
• Maintained accurate digital patient records ensuring compliance with clinical documentation standards, infection control protocols, and healthcare regulations.
• Assisted in diagnostic processes including radiograph handling, case documentation, and treatment coordination with senior dentists.
• Participated in clinic workflow optimization using SaaS-based tools for appointment tracking, patient communication, and reporting.
• Organized and executed community outreach and dental camps, providing screening and preventive care services to 300+ individuals.
• Applied infection control and sterilization protocols (PPE usage, instrument sterilization, operatory disinfection) in accordance with clinical safety standards.
• Supported public health initiatives focusing on oral disease prevention, awareness campaigns, and early diagnosis strategies.
• Collaborated with multidisciplinary teams, contributing to patient care coordination and improving service delivery efficiency.

Master of Public Health in Health Education & Promotion – Texas State University, San Marcos, TX (2025-05)

Bachelor of Dental Surgery – SIBAR Institute of Dental Sciences, India (2022-12)