R.

DIVYA
Mobile: +91 7995711409
Email: [email protected]

OBJECTIVE:

As a Statistical Programmer, I will leverage my advanced SAS programming skills and proficiency in CDISC standards to
support or lead one or more Phase I-IV clinical trials.

PROFESSIONAL SUMMARY:
➢ Having 3 years of programming experience in clinical domain using SAS-Release 9.2/9.4 and UNIX environment.
➢ Demonstrated success in the assurance of deliverable quality and process compliance.
➢ Ability to anticipate stakeholder and regulatory requirements.
➢ Have good working experience in SAS /BASE, SAS/MACRO, SAS/SQL.
➢ Knowledge on Clinical Terminol.ogy and Regulatory guidelines.
➢ Strong knowledge of Oncology TA studies.
➢ Independently program SDTM, ADaM datasets (TU, TR, RS, ADTTE, etc.).
➢ Using RECIST criteria for, PFS, Survival Analysis, and other Response endpoints
➢ Good understanding of Study Protocols, SAP (Statistical analysis plan) and CRF’s.
➢ Having Good Experience in creating ADaMs and Validation of ADaMs followed by SAP and Specification.
➢ Slight knowledge in Reviewing ADaMs specifications followed by Mock shells.
➢ Generated Various Tables and Listings using reports using PROC REPORT, PROC MEANS, PROC FREQ, PROC
TRANSPOSE AND MACRO STATEMENTS as per mock shells using analysis datasets and Validating Tables and
Listings.
➢ Experience in SAS and Statistical programming including data steps, procedures; systems and database expertise.
➢ Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed.
➢ Comprehension of statistical terminology and concepts Designs and develops complex programming algorithms.
➢ Good communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well
with change and seamlessly assimilates to new projects and stakeholders.
➢ Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind
that optimize analysis and reporting and leverage departmental standards and industry best-practices.
➢ Having knowledge on R.
➢ Navigating RStudio interface
➢ Data manipulation with packages like "dplyr", “plotly” data visualization using "ggplot2", statistical analysis with base
R functions.
➢ Data cleaning, and proficiency with RStudio.
➢ Creating visualizations with ggplot2 (bar charts, scatter plots).
➢ Proficiency in generating tables and reports with packages like knitr or rmarkdown
➢ Importing data from various sources (CSV, Excel, databases) using readr, readxl packages.
➢ Data transformation (e.g., converting data types, creating new variables) using dplyr functions
like mutate, transmute, recode.

TECHNICAL SKILLS:
➢ Operating systems : UNIX, WINDOWS
➢ Programming : Base SAS, Advance SAS, SQL,
➢ MS Office : Word, Excel, PowerPoint
➢ Clinical Standards : CDISC SDTM

WORK EXPERINCE:

Organization: – Accenture (Mar 2019 to till now)

Responsibilities:
➢ Using Base SAS and Macros to generate SDTM, ADaM, Tables and Listings.
➢ Involved in creation and validation of SDTM, ADAM’s datasets.
➢ Developing and validating SDTM, ADaM and TLF’S as per CDISC and client Standards.
➢ Generating tables, listings, summary reports that plays a prominent role for to identify the safety and efficacy of the
drugs.
➢ Creation of Tables, Listings and Figures (TLFs) for multiple studies.
➢ conformance with the given specifications and industry/company standards.
➢ Producing nearly defect-free output by doing quality coding and review
➢ Attended/Completed many trainings/sessions (including both on Pharma domain and SAS) to meet
Client’s requirements.
➢ Working on multiple protocols and/or drug compounds at a time.
➢ Actively contributing on process improvement and non-clinical project initiatives.
 ➢ Validated datasets by using proc compare and pinnacle 21.
➢ Adaptable in organizing the things and able to work in a team or independently which can expand my growth along
with the organization
➢ Executing analyses specified in the Statistical Analysis Plan (SAP) or Report and Analysis Plan (RAP) under the
guidance of the project statistician.
➢ Validation of datasets and peer reviewing of the fellow programmers’ code.
➢ Data validation for finding data discrepancies.
➢ Data Profiling, Data cleaning and data validation using SAS regular expressions.
➢ Creating macros to optimize code.
➢ Worked on development of spec creation and define. Xml. Reports
➢ Build and maintain effective working relationship with cross-functional team.
➢ Navigating R Studio interface.
➢ Data manipulation with packages like "dplyr", “plotly” data visualization using "ggplot2", statistical analysis with base R
functions.
➢ Data cleaning, and proficiency with RStudio.
➢ Creating visualizations with ggplot2 (bar charts, scatter plots).
➢ Proficiency in generating tables and reports with packages like knitr or rmarkdown.
➢ Importing data from various sources (CSV, Excel, databases) using readr, readxl packages.

Organization: – Bio Clin Pharma (Mar 2013 to 2017)

Responsibilities:

➢ Communicate with the Statisticians, Data managers to provide SAS programming in analyzing Clinical Trial Data, Generating
final SDTM Datasets.
➢ Develop standard macros and/or tools in SAS for data analysis and reporting.
➢ Assist with statistical quality assurance review.
➢ Review deliverables before transfer to either internal or external clients.
➢ Experience in performing different operations on data sets of any size like Sorting, Merging and Concatenating.
➢ Involved in Creation of datasets, tables, listings, and figures as per specifications.
➢ Ability to build and maintain good relationship with the onshore and Peers.