Swetha Palle
Hyderabad
Summary
Certified SAS Programmer with 7+ years of experience in statistical programming within pharmaceutical environments. Expertise in SAS programming for clinical trials across phases I, II, and III, with a strong grasp of CDISC SDTM standards, and legacy data conversion. Proficient in Quality Control and validation of analysis datasets, with a solid understanding of regulatory requirements and processes, from IND submission to FDA approval. Experience spans therapeutic areas, including Respiratory, Cardiovascular, Neurology, and Oncology, with skills in SQL and R enhancing analytical capabilities. Committed job seeker with a history of meeting company needs with consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Senior Statistical Programmer
Mountain IT Solutions
Lewisville,Texas
02.2024 - Current
- Created CDISC datasets, tables, figures, and listings from detailed instructions provided by biostatisticians and statistical programmers.
- Developed and modified SAS programs to load external data, and create study-specific datasets for reporting.
- Generated listings, tables, figures (TLGs/TLFs), and ad-hoc reports utilizing Proc Report and Proc SGPLOT.
- Produced ADaMs and tables/listings for integrated summaries of efficacy (ISE) and safety (ISS) for FDA submission.
- Provided technical leadership in a team environment, addressing moderate to high-complexity clinical trial reporting issues.
- Communicated issues promptly to the Programming/Statistics lead and functional managers as needed.
- Maintained extensive knowledge of medical data, clinical trial design, statistics, regulatory requirements, and the pharmaceutical industry.
- Performed quality control checks on SAS code and outputs produced by other statistical programmers.
Statistical Programmer II
Mountain IT Solutions
Lewisville, Texas
06.2021 - 02.2024
- Ensured compliance with Standard Operating Procedures, and FDA GCP guidelines for all reporting activities.
- Conducted PK/PD data analysis by creating PC and PP SDTM datasets.
- Developed SDTM datasets and produced CDISC deliverables, including a CRF and define.xml.
- Reviewed study protocols, Statistical Analysis Plans, and related documents prior to programming.
- Transformed raw datasets into SDTM formats for subsequent ADaM dataset creation.
- Created specifications aligning clinical studies with SDTMIG and ADaMIG requirements.
- Modified existing data using set, merge, sort, update, formats, functions, and conditional statements.
- Generated tables, listings, graphs, and analysis datasets using Proc Freq, Proc Report, and Proc Tabulate.
Statistical Programmer I
Mountain IT Solutions
Lewisville, Texas
03.2018 - 06.2021
- Validated analysis datasets by cross-referencing each variable against specified tables and listings.
- Conducted statistical analyses, tabulations, graphics, and listings for clinical trial data.
- Extracted internal and external data, ensuring thorough cleaning, validation, and analysis prior to report generation.
- Performed validation of tables and listings for clinical study reports.
- Worked across various clinical trial domains, including Demographics (DM), Adverse Events (AE), and Medical History (MH).
- Validated CDISC SDTM domains utilizing Pinnacle 21 to ensure compliance with standards.
- Ensured adherence to all BDM SOPs, and relevant procedures throughout the project lifecycle.
- Developed SDTM annotations and reviewed ADaM specifications to support client projects.
Education
Bachelor of Science -
Jawaharlal Nehru Technological University
05-2006
Skills
- CDISC standards
- SDTM and ADaM expertise
- Data visualization
- SAS macros development
- TFLs
- Documentation specifications
- aCRF knowledge
- Data quality assurance
- Data management strategies
- Time management
- ISS/ISE understanding
- SAS programming
- Problem solving
SKILLS
Languages : SAS (Interactive, EG, Studio), SQL
Databases : MS Access, SQL Server and Oracle
Business Tools : MS Word, MS Excel, Office 365.
Operating Systems : Windows 10, Unix
Certification
- SAS Certified Base Programmer for SAS 9
- SAS Certified Advanced Programmer for SAS 9
Timeline
Senior Statistical Programmer
Mountain IT Solutions
02.2024 - Current
Statistical Programmer II
Mountain IT Solutions
06.2021 - 02.2024
Statistical Programmer I
Mountain IT Solutions
03.2018 - 06.2021
Bachelor of Science -
Jawaharlal Nehru Technological University
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