Summary
Overview
Work History
Education
Skills
SKILLS
Certification
Timeline
Generic

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
Swetha Palle