Statistical Programmer II

Role: Statistical Programmer II


Location : Tampa, Florida

Job Duties:

Roles and responsibilities she perfomed as a Statistical Programmer I/ Sas Programmer I from
Sep2019 - Jan2021 Includes the follows:
Provide statistical programming support for the reporting of clinical trial results of Phase 1
and Phase 2
Experience working with systems used within the Clinical Trial process.
Generated program as per STDM standards and Documentation of SAS code, log, Output
and report as per SOP guidelines.
Performed CDISC Mapping for Ongoing clinical trials and classified data into domains.
understanding with CDISC SDTM Implementation Guide v3.1.2/ v3.1.3 and SDTM
Model.
Proficient in generating clinical reports for safety analysis in the form of tables and listings.
Developed reports for safety as per study requirements debugging SAS errors and
identifying issues producing reports or analysis data sets and SAS data sets.
Roles and responsibilities she perfomed as a Statistical Programmer II/ Sas Programmer II from
feb2021 - Dec2022 Includes the follows:
Experienced in Writing statistical programs using SAS and R as per requests from internal
or external clients and reviewing the statistical analysis plan (SAP), SDRG and ADRG.
Handling of multiple Projects of client data to analyze Phase II and Phase III Clinical trials
data in various therapeutic areas like Hematology, endocrinology, Dermatology,
Gastroenterology, Immunology, Neurology and Virology to provide statistical
programming by using SAS tools such as SAS/MACROS, SAS/SQL and R experience for
the reporting of clinical trial results.
Involved in error handling, fixing bugs, and overcoming the challenges faced while
developing the code of specified structure of Tables and listings through creating Macros
and macro variables.
Experienced in data validation and data cleaning and worked understanding with CDISC
SDTM Implementation Guide v3.2/v3.3 and SDTM Model checks (through specifications) on
clinical trial datasets and QC of Statistical/ Programming outputs like Analysis Datasets and
aCRF (Case Report Form).
Experienced in creating reports using proc report and derived data sets (SDTM, CDISC,
ADAM) and Generated Define.xml output for FDA regulatory submissions.
Created efficacy customize reports for FDA regulatory submissions and develop to
maintain SAS programs to create SDTM and Adam datasets and created Tables and
Figures to support clinical trials.
Track clinical trial milestones for statistical programming deliverables.
Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and
international regulations, and participate in internal/external audits and regulatory
inspections as required.


Analyzed and validated data sets and SAS outputs with other programmer's outputs and
mockups in SAP using PROC COMPARE, PROC CONTENTS and PROC FREQ. Created
formats for the coded data and used PROC SQL for data validation.