• Developed SAS programs/Macros to generate graphs and
reports based on combined datasets and performed statistical analyses with
output delivery procedures.

• Creating TLF’s in CDARS (Clinical Data Analysis and
Reporting System) tool.

• Collaborating with clinical researchers in the design of
clinical trial selection of clinical endpoints, sample size requirements,
protocol development, and Research and Case Report Form.

• Reviewing CRF's, Protocol, SAP of the clinical trial and
company SOP.

• Integrating data from multiple studies for ISS and ISE.

• Generating Safety tables (ISS) under tight timelines as
per the requirements of the Statistician and ISS/ISE SAP

• Producing ODS statements to generate different output
formats like HTML, PDF and excel to view them in the web

browser.

• Creating Patient Profiles as per the requirement at study
level for special interest AEs(narratives).

• Mapping from PDS to CDISC standards.

• Creating electronic datasets (i.e., SAS Transport Files)
for submission by using PROC EXPORT for FDA submission.

• Writing and updating the specifications for CDISC ADaM
datasets following ADaM IG guidelines, annotated mockup

shells and internal standards.

• Creating and validating ADaM datasets based on ADaM specs
like ADSL, ADMH, ADAE, ADCM, ADVS etc.

• Cleaning existing data and converted them into useful SAS
Datasets, merged datasets and created reports based on

Ad-hoc requirements.

• Producing quality customized reports by using PROC
TABULATE, REPORT and SUMMARY and provided descriptive

statistics using PROC MEANS, FREQ and UNIVARIATE.

• Importing raw data files in excel format in SAS and
subsequently created SAS Datasets and performed data

manipulations on the datasets.

• Validating and documenting SAS programs, tables, listings,
and graphs Coordinated with the lead statistician and the

lead programmer.

• Cross-validating SAS programs authored by other SAS
programmers as a part of QA (quality assurance).

• Performing quality control (QC) methods and processed
programming deliverables in both study and submission

level activities.

• Extracting the data from various internal and external
databases (Excel spreadsheets) using SAS/ACCESS, SAS/INPUT.

• Participating in clinical project meetings and provided
input, whenever relevant.

• Conducting data quality and consistency check and write
edit check using SAS programs.

• Deriving analysis safety and efficacy analysis data sets
from raw SAS datasets (Demographics, LAB, Adverse Events,Medical History,
Physical Examination, ECG, Concomitant Medications, Overall, Pain, Vital Signs,
and Concomitant Medication) as per Statistical Analysis Plan (SAP).