Sruthika Podduturi
Summary
- Professional clinical SAS Programmer with over 4 years of experience in using SAS for Analysis and Reporting in Pharmaceutical industries.
- Experience in creating SDTM Deliverables, SAS Datasets, Tables, Listings and Graphs according to CDISC requirements, Sponsor Standard Operating Procedures (SOPs) and Statistical Analysis Plan (SAP).
- Experience in Data Manipulation procedures such as SAS Formats / In-formats, Merge, Proc Append, Proc Datasets, Proc Sort and Proc Transpose.
- Experience in producing various output formats including HTML, RTF, using SAS statements, procedures, ODS(Output Delivery systems), Proc Report, Proc Tabulate in Clinical Trials.
- Experience in conducting clinical trials (Phase I, II, III) and their designs including open-labeled, single blinded, double blinded, randomized and crossover studies.
- Good knowledge of (ICH-GCP) International Council for Harmonization-Good Clinical Practice and Regulatory Guidelines (FDA) in compliance with 21CFR Part 11 (NDA & IND submissions).
- Maintain information, documentation in Clinical Trial management systems and other sponsor appropriate systems.
- Assisted in Site-monitoring activities including study start-up, study maintenance and study close-out according with Local Laws & Regulations, sponsor clinical trial protocol.
- Worked with Internal and external stakeholders, acted as a primary point of contact throughout all phases of clinical study.
- Proficient in understanding Study Protocols, SAP (Statistical Analysis Plan), and CRFs.
- Adaptability and ability to understand job requirements, new methods, ideas, concepts, and technologies.
Overview
5
5
years of professional experience
Work History
Clinical SAS Programmer
Sri Pharma Tech Inc
New Jersey
06.2022 - Current
- Worked with datasets to extract customized reports of the Clinical trial data such as Demographic data(DM), Medical History(MH) data, Adverse events (AE) Data, Serious Adverse Events (SAE), Event Assessment Data, Laboratory Data(LB)
- Ensure SAS programs adhere to specifications
- Develop and review specifications for SDTM, update blank CRFs with SDTM, and develop define.xml file for SDTM
- Looking after the Quality of the SDTM outputs, Analysis dataset, proc compare of the datasets, finding issues in production outputs and maintaining relevant QC Documentation
- Wrote independent programs as well as Used Pinnacle 21 tool to validate SDTM datasets and created pinnacle reports
- Created transport files of analysis datasets and reviewed the submission package (including Define.xml ADRG)
- Extensive use of SAS/BASE and SAS/STAT for producing tables, listings, figures, and generating statistical reports
- Used Output Delivery System (ODS) facility to write custom safety and efficacy reports directing SAS output to RTF and HTML files
- Done stacking and merging of various datasets
- Review the protocol, case report forms (CRFs), statistical analysis plan (SAP) for Clinical Trials
- Involved in the reviewing of SAP, Prepared and documented programming specification
- Extensively used SAS procedures Print, Report, Sort, SQL, Mean, Freq etc
- To analyze data and produce reports.
Clinical Research Assistant
Novartis Pharmaceuticals Inc
Hyderabad
06.2019 - 12.2021
- Responsible for coordinating and overseeing the execution of studies and clinical trials
- Ensure the study site follows all local and federal laws and regulations
- Recruit and enroll study participants
- Input clinical research data into electronic data systems
- Conduct informed consent process and conduct study related visits
- Monitor subjects per protocol requirements
- Assess, monitor, and report adverse events per protocol
- Maintain required records of study activity including source documentation, case report forms, drug dispensation records, and data management system entry
- Manage quality assurance activities for assigned protocols per site SOP’s
- Ensure adherence to study protocols and study quality, maintains subject confidentiality
- Worked with Biostatisticians for analysis and reporting of Study data in accordance with CDISC SDTM standards.
Education
Master’s - Health Informatics
Sacred Heart University
03.2023
Bachelors - Pharmacy
Jawaharlal Nehru University
05.2019
Skills
- Good knowledge of Electronic Health Records (EHR), Electronic Medical Records (EMR), US Health Insurance Portability and Accountability Act (HIPAA), GCP guidelines, Tableau, etc
- Good at Primary and Secondary Research of the data
- Project Management Protocol Development
- Cross-functional Collaboration
- Regulatory Compliance
- Risk Management
- Vendor Management
- Data Management & Quality Assurance
- Effective communication and problem-solving skills
Technical Skills
SAS Tools : SAS/BASE, SAS/ACCESS, SAS/CONNECT, SAS/SQL, SAS/REPORTS, SAS/STAT,
SAS/MACROS, SAS/ODS and SAS/GRAPH
SAS Process : Print, Means, Tabulate, Univariate, SQL, Report, Freq, Sort, Summary, Format,
Export, Transpose, Compare, G-plot and G-chart.
Languages : C, SQL, PL/SQL, HTML and XML
Databases : MS Access, SQL Server and Oracle
Business Tools : Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook.
Operating Systems : Windows, LINUX
Timeline
Clinical SAS Programmer
Sri Pharma Tech Inc
06.2022 - Current
Clinical Research Assistant
Novartis Pharmaceuticals Inc
06.2019 - 12.2021
Master’s - Health Informatics
Sacred Heart University
Bachelors - Pharmacy
Jawaharlal Nehru University
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