Experienced clinical SAS programmer with over 2 years of expertise in the medical field.
Possessing in-depth knowledge of SAS programming and a SAS 9.4 global certification,
I hold a Bachelor’s degree in pharmacy.
Seeking a challenging clinical/statistical programmer position to leverage my skills and experience in clinical trials and
data analysis for the betterment of patient outcomes in a reputed organization.
Technical Project Experience
- CRF Annotations
Annotations are meant to find the origin of data variables included in the submitted datasets. Check
for the fields available in CRF and to which SDTM variable it is mapped, and annotate accordingly.
- SDTM Data Development
Created the SDTM Demography dataset by writing independent code in SAS. extract variables from
Randomization, disposition, trial arms, DM, and derive variables as per the requirements of DM
domain Referring to the SDTM IG v3.4, assign the specified length and labels conversion of date time
variables into ISO 8601 formats.
- Analysis Data Development
Developed laboratory analysis dataset (ADLB) by using lab data (LB) and ADSL data (Subject Level
Analysis dataset) for specified lab tests. Derive the baseline values, change from the baseline, and
percent change. variables and derived flags for various criteria.
- Analysis Data validation
Validated an analysis-ready dataset Generated from VS. Derived variables and flags for VSNCODE,
VSBSL, VSDURN, BSLFLG, etc., comparing the created dataset with the dataset to be validated, submit
comparison results in the form of HTML or listing format as per specification.
- Integrating data for Pk analysis
Defining the technical integration of Pk concentration data and corresponding PK data in the clinical
database. database-concentration data gained from LB analysis of samples during PK study, DM,
baseline VS values, dose administration details, blood collection log of subjects.
- Report Generation
Generated a report for the Summary of Demography for the intravenous treatment groups. and TEAE
by the MedDRA system organ class for a safety-evaluable population, applying templates and styles
to generate reports with an ODS as per the mock shell.
- Report validation
Validated reports for demographics and baseline characteristics, Medical History as per the preferred
term (MedDRA) for the number (%) of subjects reporting an event by calculating descriptive statistics
and frequency distribution.
- Advanced Report generation
- Summary of Physical examination (Safety Analysis Set)
- Summary of Medical / Surgical History (Enrolled Population set)
- Summary of Dose limiting toxicities (Safety Population)
- Analysis of Response Criteria for Tumour Assessment (Per protocol Population)
Global Certifications (if any)
Bachelor's in pharmacy with first class in academics.
Work & Experience
Primarily responsible for the quality and timely delivery of CDISC and client-specific standard artifacts by understanding clinical study protocols, SAP, CRFs, and specifications. Develop and validate derived datasets/analysis datasets/SDTM/ADaM. Importing and exporting raw data, creating reports using SAS procedures, combining sets of SAS data, building statistical tables to show information and correcting errors of programming. Communicate with project team and SME for clarity of specifications, data issues, outliers, reviews and schedules etc. Show commitment and perform high quality work.